Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Gap Panel
Kinamed, Inc.
14-1P3-0886
In Commercial Distribution

  • 00898142001111 ()
14-1P3-0886

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Bone Plate
Kinamed, Inc.
14-1P2-0122
In Commercial Distribution

  • 00898142001104 ()
14-1P2-0122

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Bone Plate, Slotted
Kinamed, Inc.
14-1P2-0318
In Commercial Distribution

  • 00898142001098 ()
14-1P2-0318

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Bone Plate, Ported
Kinamed, Inc.
14-1P2-0218
In Commercial Distribution

  • 00898142001081 ()
14-1P2-0218

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Bone Plate
Kinamed, Inc.
14-1P2-0118
In Commercial Distribution

  • 00898142001074 ()
14-1P2-0118

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Bone Plate
Kinamed, Inc.
14-1P2-0114
In Commercial Distribution

  • 00898142001067 ()
14-1P2-0114

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Bone Plate
Kinamed, Inc.
14-1P1-0413
In Commercial Distribution

  • 00898142001050 ()
14-1P1-0413

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Bone Plate
Kinamed, Inc.
14-1P1-1266
In Commercial Distribution

  • 00898142001043 ()
14-1P1-1266

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Bone Plate
Kinamed, Inc.
14-1P1-0812
In Commercial Distribution

  • 00898142001036 ()
14-1P1-0812

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Bone Plate
Kinamed, Inc.
14-1P1-0810
In Commercial Distribution

  • 00898142001029 ()
14-1P1-0810

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Bone Plate
Kinamed, Inc.
14-1P1-0612
In Commercial Distribution

  • 00898142001012 ()
14-1P1-0612

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Bone Plate
Kinamed, Inc.
14-1P1-0211
In Commercial Distribution

  • 00898142001005 ()
14-1P1-0211

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Reform Ti CT Cannulated T25 Poly Driver, Stealth Navigation
PRECISION SPINE, INC.
70-RT-1750
In Commercial Distribution

  • 00840019942775 ()
70-RT-1750

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Adjustment Driver - T25
PRECISION SPINE, INC.
64-SP-0601
In Commercial Distribution

  • 00840019942461 ()
64-SP-0601

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Angled Self-Retaining Driver - Short
PRECISION SPINE, INC.
71-IN-0415
In Commercial Distribution

  • 00840019941877 ()
71-IN-0415

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Angled Self-Retaining Driver
PRECISION SPINE, INC.
71-IN-0400
In Commercial Distribution

  • 00840019941860 ()
71-IN-0400

  • Orthopaedic surgical procedure kit, non-medicated, reusable
SureLOK MIS 3L Polyaxial Driver, Navigated
PRECISION SPINE, INC.
70-3L-0700
In Commercial Distribution

  • 00840019939171 ()
70-3L-0700

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Reform Ti Polyaxial Driver, Cannulated, Navigated
PRECISION SPINE, INC.
70-RT-1720
In Commercial Distribution

  • 00840019939096 ()
70-RT-1720

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Reform Modular Driver, Non-Cannulated, Navigated
PRECISION SPINE, INC.
70-RM-0800
In Commercial Distribution

  • 00840019939072 ()
70-RM-0800

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Reform Polyaxial Driver, Non-Cannulated, Navigated
PRECISION SPINE, INC.
70-RF-0700
In Commercial Distribution

  • 00840019939003 ()
70-RF-0700

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Reform MC Modular Driver, Non-Cannulated, Navigated
PRECISION SPINE, INC.
70-MC-0800
In Commercial Distribution

  • 00840019938907 ()
70-MC-0800

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Rivet Driver - T8
PRECISION SPINE, INC.
65-IN-0060
In Commercial Distribution

  • 00840019937955 ()
65-IN-0060

  • Orthopaedic surgical procedure kit, non-medicated, reusable
BAND DRIVER OFFSET TIP S/STEEL MARC D
LEONE SPA
X0009
In Commercial Distribution

  • 08033707075462 ()
X0009

  • Orthodontic metal band pusher
Reduction Locking Polyaxial Driver
PRECISION SPINE, INC.
39-SP-0740
In Commercial Distribution

  • 00840019935890 ()
39-SP-0740

  • Orthopaedic surgical procedure kit, non-medicated, reusable
THE XULTAN 5.5 PEDICLE SCREW SYSTEM IS AN IMPLANT DEVICE MANUFACTURED FROM TITANIUM AND SILICONE. THE SCREWS ARE AVAILABLE CANNULATED OR NON-CANNULATED IN VARIOUS DIAMETERS AND LENGTHS TO ACCOMMODATE VARIOUS PATIENT ANATOMIES. THE SYSTEM INCLUDES STRAIGHT RODS, CURVED RODS, CROSSLINKS, AND ASSOCIATED INSTRUMENTATION.
MET 1 TECHNOLOGIES, LLC
30290309
In Commercial Distribution

  • 00819824023986 ()
30290309

  • Surgical screwdriver, reusable
THE XULTAN 5.5 PEDICLE SCREW SYSTEM IS AN IMPLANT DEVICE MANUFACTURED FROM TITANIUM AND SILICONE. THE SCREWS ARE AVAILABLE CANNULATED OR NON-CANNULATED IN VARIOUS DIAMETERS AND LENGTHS TO ACCOMMODATE VARIOUS PATIENT ANATOMIES. THE SYSTEM INCLUDES STRAIGHT RODS, CURVED RODS, CROSSLINKS, AND ASSOCIATED INSTRUMENTATION.
MET 1 TECHNOLOGIES, LLC
30290332
In Commercial Distribution

  • 00819824023832 ()
30290332

  • Surgical screwdriver, reusable
THE XULTAN 5.5 PEDICLE SCREW SYSTEM IS AN IMPLANT DEVICE MANUFACTURED FROM TITANIUM AND SILICONE. THE SCREWS ARE AVAILABLE CANNULATED OR NON-CANNULATED IN VARIOUS DIAMETERS AND LENGTHS TO ACCOMMODATE VARIOUS PATIENT ANATOMIES. THE SYSTEM INCLUDES STRAIGHT RODS, CURVED RODS, CROSSLINKS, AND ASSOCIATED INSTRUMENTATION.
MET 1 TECHNOLOGIES, LLC
300290347
In Commercial Distribution

  • 00819824023788 ()
30290347

  • Surgical screwdriver, reusable
THE XULTAN 5.5 PEDICLE SCREW SYSTEM IS AN IMPLANT DEVICE MANUFACTURED FROM TITANIUM AND SILICONE. THE SCREWS ARE AVAILABLE CANNULATED OR NON-CANNULATED IN VARIOUS DIAMETERS AND LENGTHS TO ACCOMMODATE VARIOUS PATIENT ANATOMIES. THE SYSTEM INCLUDES STRAIGHT RODS, CURVED RODS, CROSSLINKS, AND ASSOCIATED INSTRUMENTATION.
MET 1 TECHNOLOGIES, LLC
30290348
In Commercial Distribution

  • 00819824023757 ()
30290348

  • Orthopaedic inorganic implant inserter/extractor, reusable
THE XULTAN 5.5 PEDICLE SCREW SYSTEM IS AN IMPLANT DEVICE MANUFACTURED FROM TITANIUM AND SILICONE. THE SCREWS ARE AVAILABLE CANNULATED OR NON-CANNULATED IN VARIOUS DIAMETERS AND LENGTHS TO ACCOMMODATE VARIOUS PATIENT ANATOMIES. THE SYSTEM INCLUDES STRAIGHT RODS, CURVED RODS, CROSSLINKS, AND ASSOCIATED INSTRUMENTATION.
MET 1 TECHNOLOGIES, LLC
30290310
In Commercial Distribution

  • 00819824023627 ()
30290310

  • Surgical screwdriver, reusable
Driver, T15 NSR, 200mm, AO Quick Connect
GLOBUS MEDICAL, INC.
6187.3815
In Commercial Distribution

  • 00889095716634 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Driver, T15 SR, 170mm, AO Quick Connect
GLOBUS MEDICAL, INC.
6187.3715
In Commercial Distribution

  • 00889095716610 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
8mm Self Retaining Driver Shaft
GLOBUS MEDICAL, INC.
6183.1102
In Commercial Distribution

  • 00889095711745 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Retention Bolt Driver
GLOBUS MEDICAL, INC.
6176.0027
In Commercial Distribution

  • 00889095711318 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Locking Screw Driver, Long, for Power
GLOBUS MEDICAL, INC.
6176.0057
In Commercial Distribution

  • 00889095660869 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Locking Screw Driver, Short, for Power
GLOBUS MEDICAL, INC.
6176.0055
In Commercial Distribution

  • 00889095660845 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Locking Screw Driver, Short
GLOBUS MEDICAL, INC.
6176.0045
In Commercial Distribution

  • 00889095660838 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Locking Screw Driver, Long
GLOBUS MEDICAL, INC.
6176.0042
In Commercial Distribution

  • 00889095660814 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Angled Driver Tip, T10
GLOBUS MEDICAL, INC.
651.070
In Commercial Distribution

  • 00889095639544 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Multitool
GLOBUS MEDICAL, INC.
6173.0111
In Commercial Distribution

  • 00889095621396 ()


  • Surgical screwdriver, reusable
11mm Hex Driver, T-Handle
GLOBUS MEDICAL, INC.
6148.3050
In Commercial Distribution

  • 00889095495140 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Stick Driver, Power
GLOBUS MEDICAL, INC.
6148.1101
In Commercial Distribution

  • 00889095495058 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Stick Driver, 1/4" Quick-connect
GLOBUS MEDICAL, INC.
6148.1100
In Commercial Distribution

  • 00889095495041 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
3.5mm Hex Driver, 1/4" Quick-Connect
GLOBUS MEDICAL, INC.
6148.0050
In Commercial Distribution

  • 00889095494969 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
11mm Hex Driver, 1/4" Quick-Connect
GLOBUS MEDICAL, INC.
6148.0045
In Commercial Distribution

  • 00889095494952 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Torque Limiting 11mm Hex Driver, L-Handle, 12Nm
GLOBUS MEDICAL, INC.
6148.0041
In Commercial Distribution

  • 00889095494945 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Easy-Out Extraction Driver, AO Quick Connect
GLOBUS MEDICAL, INC.
6179.7026
In Commercial Distribution

  • 00889095489439 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
4.0mm Headless Driver
GLOBUS MEDICAL, INC.
6188.6240
In Commercial Distribution

  • 00889095721782 ()

  • Bone Thread Diameter 4.0mm


  • Orthopaedic surgical procedure kit, non-medicated, reusable
3.0mm Headless Driver
GLOBUS MEDICAL, INC.
6188.6230
In Commercial Distribution

  • 00889095721775 ()

  • Bone Thread Diameter 3.0mm


  • Orthopaedic surgical procedure kit, non-medicated, reusable
2.5mm Headless Driver
GLOBUS MEDICAL, INC.
6188.6225
In Commercial Distribution

  • 00889095721768 ()

  • Bone Thread Diameter 2.5mm


  • Orthopaedic surgical procedure kit, non-medicated, reusable
T15 Driver, SR, 170mm, AO Quick Connect
GLOBUS MEDICAL, INC.
6186.6115
In Commercial Distribution

  • 00889095717631 ()

  • T15
  • Length: 170 Millimeter


  • Orthopaedic surgical procedure kit, non-medicated, reusable
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