Unique Device Identifier

  • 0 ::
      • Customer_contacts ::
          • 0 ::
              • Phone : +1(800)633-8766
                • Email : Corporate.UDI@medtronic.com
          • Is_rx : true
            • Is_kit : false
              • Brand_name : Midas Rex™
                • Has_expiration_date : false
                  • Has_serial_number : false
                    • Has_lot_or_batch_number : true
                      • Is_single_use : false
                        • Is_otc : false
                          • Record_status : Published
                            • Is_labeled_as_no_nrl : false
                              • Device_count_in_base_package : 1
                                • Is_combination_product : false
                                  • Is_pm_exempt : false
                                    • Company_name : MEDTRONIC POWERED SURGICAL SOLUTIONS
                                      • Mri_safety : Labeling does not contain MRI Safety Information
                                        • Commercial_distribution_status : In Commercial Distribution
                                          • Device_description : TOOL T14MH25M LEGEND 14CM 2.5MM MH 2FLT
                                            • Sterilization ::
                                                • Is_sterilization_prior_use : false
                                                  • Is_sterile : true
                                                • Is_labeled_as_nrl : false
                                                  • Is_direct_marking_exempt : false
                                                    • Version_or_model_number : T14MH25M
                                                      • Has_donation_id_number : false
                                                        • Has_manufacturing_date : false
                                                          • Identifiers ::
                                                              • 0 ::
                                                                  • Issuing_agency : GS1
                                                                    • Type : Primary
                                                                      • Id : 00643169760127
                                                                • Is_hct_p : false
                                                                  • Gmdn_terms ::
                                                                      • 0 ::
                                                                          • Definition : A sterile, rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a single-use device.
                                                                            • Name : Orthopaedic bur, single-use
                                                                      • Publish_date : 2016-07-31
                                                                        • Product_codes ::
                                                                            • 0 ::
                                                                                • Code : HBB
                                                                                  • Openfda ::
                                                                                      • Regulation_number : 882.4370
                                                                                        • Medical_specialty_description : Neurology
                                                                                          • Device_class : 2
                                                                                            • Device_name : Motor, Drill, Pneumatic
                                                                                          • Name : MOTOR, DRILL, PNEUMATIC

Unique Device Identifier

  • 1 ::
      • Customer_contacts ::
          • 0 ::
              • Phone : 800-626-5463
                • Email : intl@pmtcorp.com
              • 1 ::
                  • Phone : 800-626-5463
                    • Email : info@pmtcorp.com
              • Is_rx : true
                • Is_kit : false
                  • Brand_name : MACROVAC®
                    • Has_expiration_date : false
                      • Has_serial_number : false
                        • Catalog_number : 3201-05S-03-PF
                          • Has_lot_or_batch_number : true
                            • Is_single_use : false
                              • Is_otc : false
                                • Storage ::
                                    • 0 ::
                                        • High ::
                                            • Value : 78
                                              • Unit : Degrees Fahrenheit
                                            • Type : Storage Environment Temperature
                                              • Low ::
                                                  • Value : 58
                                                    • Unit : Degrees Fahrenheit
                                          • Record_status : Published
                                            • Is_labeled_as_no_nrl : true
                                              • Device_count_in_base_package : 1
                                                • Is_combination_product : false
                                                  • Is_pm_exempt : true
                                                    • Company_name : PMT CORPORATION
                                                      • Mri_safety : Labeling does not contain MRI Safety Information
                                                        • Commercial_distribution_status : In Commercial Distribution
                                                          • Device_description : SLOTTED TIP, POLISH FINISH
                                                            • Sterilization ::
                                                                • Is_sterilization_prior_use : true
                                                                  • Sterilization_methods : Moist Heat or Steam Sterilization
                                                                    • Is_sterile : false
                                                                  • Device_sizes ::
                                                                      • 0 ::
                                                                          • Type : Catheter Gauge
                                                                            • Unit : French
                                                                              • Value : 5
                                                                            • 1 ::
                                                                                • Type : Length
                                                                                  • Unit : Inch
                                                                                    • Value : 3
                                                                              • Is_labeled_as_nrl : false
                                                                                • Is_direct_marking_exempt : false
                                                                                  • Version_or_model_number : 3201-05S-03-PF
                                                                                    • Has_donation_id_number : false
                                                                                      • Has_manufacturing_date : false
                                                                                        • Identifiers ::
                                                                                            • 0 ::
                                                                                                • Issuing_agency : GS1
                                                                                                  • Type : Primary
                                                                                                    • Id : 00650551027096
                                                                                              • Is_hct_p : false
                                                                                                • Gmdn_terms ::
                                                                                                    • 0 ::
                                                                                                        • Definition : A hand-held device designed to regulate and direct a stream of pressurized, warmed fluid (e.g., sterile water or saline) and alternatively provide aspiration (suction) to a surgical site for the purpose of irrigating and clearing debris from the field of intervention. It is fitted with a long syringe-like nozzle that is activated by the user, typically through a push-type control(s). This device is typically a component of a surgical irrigation/aspiration system used for ENT or neurological surgery. This is a reusable device.
                                                                                                          • Name : Surgical irrigation/aspiration handpiece
                                                                                                    • Publish_date : 2016-08-01
                                                                                                      • Product_codes ::
                                                                                                          • 0 ::
                                                                                                              • Code : GZX
                                                                                                                • Openfda ::
                                                                                                                    • Regulation_number : 882.4525
                                                                                                                      • Medical_specialty_description : Neurology
                                                                                                                        • Device_class : 1
                                                                                                                          • Device_name : Instrument, Microsurgical
                                                                                                                        • Name : Instrument, Microsurgical

Unique Device Identifier

  • 2 ::
      • Customer_contacts ::
          • 0 ::
              • Phone : 800-626-5463
                • Email : intl@pmtcorp.com
              • 1 ::
                  • Phone : 800-626-5463
                    • Email : info@pmtcorp.com
              • Is_rx : true
                • Is_kit : false
                  • Brand_name : CORTAC®
                    • Has_expiration_date : true
                      • Has_serial_number : false
                        • Catalog_number : 2111-32-085
                          • Has_lot_or_batch_number : true
                            • Is_single_use : true
                              • Is_otc : false
                                • Record_status : Published
                                  • Is_labeled_as_no_nrl : true
                                    • Device_count_in_base_package : 1
                                      • Is_combination_product : false
                                        • Is_pm_exempt : false
                                          • Company_name : PMT CORPORATION
                                            • Mri_safety : Labeling does not contain MRI Safety Information
                                              • Commercial_distribution_status : In Commercial Distribution
                                                • Device_description : SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 32 CONTACT, 4X8, SMOOTH, MINI CONNECTOR, 1 EXIT, 2 LEADS, 2 TAILS, ALL CONTACTS NUMBERED
                                                  • Sterilization ::
                                                      • Is_sterilization_prior_use : false
                                                        • Is_sterile : true
                                                      • Device_sizes ::
                                                          • 0 ::
                                                              • Text : Thickness 0.5 Millimeter
                                                                • Type : Device Size Text, specify
                                                              • 1 ::
                                                                  • Text : Contact Diameter 3 Millimeter
                                                                    • Type : Device Size Text, specify
                                                              • Is_labeled_as_nrl : false
                                                                • Is_direct_marking_exempt : false
                                                                  • Version_or_model_number : 2111-32-085
                                                                    • Has_donation_id_number : false
                                                                      • Has_manufacturing_date : false
                                                                        • Identifiers ::
                                                                            • 0 ::
                                                                                • Issuing_agency : GS1
                                                                                  • Type : Primary
                                                                                    • Id : 00650551065234
                                                                              • Is_hct_p : false
                                                                                • Gmdn_terms ::
                                                                                    • 0 ::
                                                                                        • Definition : An electrical conductor that is temporarily placed (< 30 days) on the surface of the brain to stimulate the brain or to record the brain's electrical activity (with more precise localization than a scalp electrode). It is typically a series of discs mounted in thin plastic strips, or in a square/rectangular grid to cover larger surface areas. The implanted device, also known as a subdural electrode, is connected to recording, monitoring, or stimulation/response devices [e.g., electroencephalograph (EEG), evoked-potential recorder, stimulator]. This is a single-use device.
                                                                                          • Name : Cortical electrode
                                                                                    • Publish_date : 2016-10-12
                                                                                      • Product_codes ::
                                                                                          • 0 ::
                                                                                              • Code : GYC
                                                                                                • Openfda ::
                                                                                                    • Regulation_number : 882.1310
                                                                                                      • Medical_specialty_description : Neurology
                                                                                                        • Device_class : 2
                                                                                                          • Device_name : Electrode, Cortical
                                                                                                        • Name : Electrode, Cortical

Unique Device Identifier

  • 3 ::
      • Customer_contacts ::
          • 0 ::
              • Phone : +1(800)423-4588
                • Email : 3Mhealthcarecompliance@mmm.com
          • Is_rx : true
            • Is_kit : false
              • Brand_name : APC™ PLUS Victory Series™ Low Profile
                • Has_expiration_date : true
                  • Has_serial_number : false
                    • Catalog_number : 5024-908
                      • Has_lot_or_batch_number : true
                        • Is_single_use : true
                          • Is_otc : false
                            • Record_status : Published
                              • Is_labeled_as_no_nrl : false
                                • Device_count_in_base_package : 5
                                  • Is_combination_product : false
                                    • Is_pm_exempt : false
                                      • Company_name : 3M UNITEK CORPORATION
                                        • Mri_safety : Labeling does not contain MRI Safety Information
                                          • Commercial_distribution_status : In Commercial Distribution
                                            • Device_description : Victory Series(TM) Low Profile Bracket APC(TM) PLUS MBT(TM) LR4 -12T/2A Hk .022 5/Pk
                                              • Sterilization ::
                                                  • Is_sterilization_prior_use : false
                                                    • Is_sterile : false
                                                  • Is_labeled_as_nrl : false
                                                    • Is_direct_marking_exempt : false
                                                      • Version_or_model_number : 5024-908
                                                        • Has_donation_id_number : false
                                                          • Has_manufacturing_date : false
                                                            • Identifiers ::
                                                                • 0 ::
                                                                    • Issuing_agency : GS1
                                                                      • Type : Primary
                                                                        • Id : 00652221096180
                                                                      • 1 ::
                                                                          • Issuing_agency : GS1
                                                                            • Type : Unit of Use
                                                                              • Id : 80652221096186
                                                                        • Is_hct_p : false
                                                                          • Gmdn_terms ::
                                                                              • 0 ::
                                                                                  • Definition : A metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.
                                                                                    • Name : Orthodontic bracket, metal
                                                                              • Publish_date : 2016-09-24
                                                                                • Product_codes ::
                                                                                    • 0 ::
                                                                                        • Code : DYH
                                                                                          • Openfda ::
                                                                                              • Regulation_number : 872.3750
                                                                                                • Medical_specialty_description : Dental
                                                                                                  • Device_class : 2
                                                                                                    • Device_name : Adhesive, Bracket And Tooth Conditioner, Resin
                                                                                                  • Name : ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

Unique Device Identifier

  • 4 ::
      • Customer_contacts ::
          • 0 ::
              • Phone : +1(800)633-8766
                • Email : Corporate.UDI@medtronic.com
          • Is_rx : true
            • Is_kit : false
              • Brand_name : PREMIER® Anterior Cervical Plate System
                • Has_expiration_date : false
                  • Has_serial_number : false
                    • Has_lot_or_batch_number : true
                      • Is_single_use : true
                        • Is_otc : false
                          • Record_status : Published
                            • Is_labeled_as_no_nrl : false
                              • Device_count_in_base_package : 1
                                • Is_combination_product : false
                                  • Is_pm_exempt : false
                                    • Company_name : MEDTRONIC SOFAMOR DANEK, INC.
                                      • Mri_safety : Labeling does not contain MRI Safety Information
                                        • Commercial_distribution_status : In Commercial Distribution
                                          • Device_description : SCREW 6860020 VA SELF TAPPING 4.0X20MM
                                            • Sterilization ::
                                                • Is_sterilization_prior_use : true
                                                  • Sterilization_methods : Moist Heat or Steam Sterilization
                                                    • Is_sterile : false
                                                  • Device_sizes ::
                                                      • 0 ::
                                                          • Type : Outer Diameter
                                                            • Unit : Millimeter
                                                              • Value : 4.0
                                                            • 1 ::
                                                                • Type : Length
                                                                  • Unit : Millimeter
                                                                    • Value : 20.0
                                                              • Is_labeled_as_nrl : false
                                                                • Is_direct_marking_exempt : false
                                                                  • Version_or_model_number : 6860020
                                                                    • Has_donation_id_number : false
                                                                      • Has_manufacturing_date : false
                                                                        • Identifiers ::
                                                                            • 0 ::
                                                                                • Issuing_agency : GS1
                                                                                  • Type : Primary
                                                                                    • Id : 00681490482110
                                                                              • Is_hct_p : false
                                                                                • Gmdn_terms ::
                                                                                    • 0 ::
                                                                                        • Definition : An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.
                                                                                          • Name : Bone-screw internal spinal fixation system, non-sterile
                                                                                    • Publish_date : 2015-08-19
                                                                                      • Product_codes ::
                                                                                          • 0 ::
                                                                                              • Code : KWQ
                                                                                                • Openfda ::
                                                                                                    • Regulation_number : 888.3060
                                                                                                      • Medical_specialty_description : Orthopedic
                                                                                                        • Device_class : 2
                                                                                                          • Device_name : Appliance, Fixation, Spinal Intervertebral Body
                                                                                                        • Name : APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY