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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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Tranquil-C™ - B6788222270

Cervical Slap Hammer
NEXUS SPINE, L.L.C.
822227
In Commercial Distribution

  • B6788222270 ()
  • B678822227 ()


  • Surgical mallet

Tranquil-L™ - B6788220020

Lumbar Slap Hammer
NEXUS SPINE, L.L.C.
822002
In Commercial Distribution

  • B6788220020 ()
  • B678822002 ()


  • Surgical mallet

PreView™ - B678821083090

Medfix Distraction Screw Driver 8" (200mm)
NEXUS SPINE, L.L.C.
821083.09
Not in Commercial Distribution

  • B678821083090 ()


  • Spinal fixation plate, non-bioabsorbable

PreView™ - B678821081090

Medfix® Distraction Screw Driver 8" (200mm)
NEXUS SPINE, L.L.C.
821081.09
Not in Commercial Distribution

  • B678821081090 ()


  • Spinal fixation plate, non-bioabsorbable

PreView™ - B6788210710

T10 Driver
NEXUS SPINE, L.L.C.
821071
In Commercial Distribution

  • B6788210710 ()
  • B678821071 ()


  • Surgical screwdriver, reusable

PreView™ - B6788210170

Rigid Driver-Cervical
NEXUS SPINE, L.L.C.
821017
In Commercial Distribution

  • B6788210170 ()
  • B678821017 ()


  • General internal orthopaedic fixation system implantation kit

N/A - 00889095220254

Tri-Lobe Driver, Small Set Screw
GLOBUS MEDICAL, INC.
650.949
In Commercial Distribution

  • 00889095220254 ()


  • Surgical screwdriver, reusable

SUSTAIN-IR - 00889095211504

Removal Tool
GLOBUS MEDICAL, INC.
6145.9100
In Commercial Distribution

  • 00889095211504 ()


  • Surgical screwdriver, reusable

N/A - 00889095259728

3.5mm Hex Driver, Short
GLOBUS MEDICAL, INC.
634.708
In Commercial Distribution

  • 00889095259728 ()


  • Surgical screwdriver, reusable

N/A - 00889095259711

6.35mm Head Positioner Hex Driver
GLOBUS MEDICAL, INC.
634.707
In Commercial Distribution

  • 00889095259711 ()


  • Surgical screwdriver, reusable

N/A - 00889095258585

3.5mm Angled Hex Driver, 10°
GLOBUS MEDICAL, INC.
6122.0504
In Commercial Distribution

  • 00889095258585 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

N/A - 00889095258554

3.5mm Hex Driver Tip, 10°
GLOBUS MEDICAL, INC.
6122.0024
In Commercial Distribution

  • 00889095258554 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

PressON™ - B6788201330

Cortical Internal Retaining Driver
NEXUS SPINE, L.L.C.
820133
In Commercial Distribution

  • B6788201330 ()
  • B678820133 ()


  • Orthopaedic implantation sleeve, reusable

PressON™ - B6788201280

Internal Retaining Driver
NEXUS SPINE, L.L.C.
820128
In Commercial Distribution

  • B6788201280 ()
  • B678820128 ()


  • Orthopaedic implantation sleeve, reusable

PressON™ - B6788201100

Cortical Screw Driver
NEXUS SPINE, L.L.C.
820110
In Commercial Distribution

  • B6788201100 ()
  • B678820110 ()


  • Surgical screwdriver, reusable

PressON™ - B6788200620

External Pedicle Driver
NEXUS SPINE, L.L.C.
820062
In Commercial Distribution

  • B6788200620 ()
  • B678820062 ()


  • Orthopaedic implant driver

PressON™ - B6788200600

Pedicle Driver
NEXUS SPINE, L.L.C.
820060
In Commercial Distribution

  • B6788200600 ()
  • B678820060 ()


  • Orthopaedic implant driver

PLIF - 10705034186498

PLIF SG INSTRUMENTS CAGE INSERTER TIP ASSEMBLY 15mm
DEPUY SPINE, LLC
273121115
In Commercial Distribution

  • 10705034186498 ()
273121115

  • Orthopaedic inorganic implant inserter/extractor, reusable

PLIF - 10705034186481

PLIF SG INSTRUMENTS CAGE INSERTER TIP ASSEMBLY 13mm
DEPUY SPINE, LLC
273121113
In Commercial Distribution

  • 10705034186481 ()
273121113

  • Orthopaedic inorganic implant inserter/extractor, reusable

PLIF - 10705034186474

PLIF SG INSTRUMENTS CAGE INSERTER TIP ASSEMBLY 11mm
DEPUY SPINE, LLC
273121111
In Commercial Distribution

  • 10705034186474 ()
273121111

  • Orthopaedic inorganic implant inserter/extractor, reusable

PLIF - 10705034186467

PLIF SG INSTRUMENTS CAGE INSERTER TIP ASSEMBLY 9mm
DEPUY SPINE, LLC
273121109
In Commercial Distribution

  • 10705034186467 ()
273121109

  • Orthopaedic inorganic implant inserter/extractor, reusable

PLIF - 10705034186351

PLIF SG INSTRUMENTS TRIAL INSERTER
DEPUY SPINE, LLC
273121001
Not in Commercial Distribution

  • 10705034186351 ()
273121001

  • Orthopaedic inorganic implant inserter/extractor, reusable

PLIF - 10705034185576

PLIF SG INSTRUMENTS SPREADER BLOCK INSERTER
DEPUY SPINE, LLC
273113201
Not in Commercial Distribution

  • 10705034185576 ()
273113201

  • Orthopaedic inorganic implant inserter/extractor, reusable

BOWTI - 10705034185316

BOWTI ANTERIOR BUTTRESS STAPLE SCREWDRIVER
DEPUY SPINE, LLC
272803100
Not in Commercial Distribution

  • 10705034185316 ()
272803100

  • Surgical screwdriver, reusable

BOWTI - 10705034185286

BOWTI ANTERIOR BUTTRESS STAPLE STAPLE INSERTER
DEPUY SPINE, LLC
272802300
Not in Commercial Distribution

  • 10705034185286 ()
272802300

  • Orthopaedic inorganic implant inserter/extractor, reusable

ISOLA - 10705034184852

ISOLA SPINE SYSTEM SCREWDRIVER
DEPUY SPINE, LLC
207001050
Not in Commercial Distribution

  • 10705034184852 ()
207001050

  • Surgical screwdriver, reusable

Neodent - 07899878064633

ZI DRIVER FOR CONTRA-ANGLE
JJGC Indústria e Comércio de Materiais Dentários S/A.
105.175
In Commercial Distribution

  • 07899878064633 ()

  • Length: 23 Millimeter
105.175

  • Dental implant system

Neodent - 07899878064626

ZI DRIVER FOR TORQUE WRENCH
JJGC Indústria e Comércio de Materiais Dentários S/A.
105.174
In Commercial Distribution

  • 07899878064626 ()

  • Length: 15 Millimeter
105.174

  • Dental implant system

Neodent - 07899878064435

NGS GM WIDE DRIVER FOR CONTRA-ANGLE
JJGC Indústria e Comércio de Materiais Dentários S/A.
105.173
In Commercial Distribution

  • 07899878064435 ()

  • Length: 33 Millimeter
105.173

  • Dental implant system

Neodent - 07899878064428

NGS GM REGULAR DRIVER FOR CONTRA-ANGLE
JJGC Indústria e Comércio de Materiais Dentários S/A.
105.172
In Commercial Distribution

  • 07899878064428 ()

  • Length: 33 Millimeter
105.172

  • Dental implant system

Neodent - 07899878064411

NGS GM NARROW DRIVER FOR CONTRA-ANGLE
JJGC Indústria e Comércio de Materiais Dentários S/A.
105.171
In Commercial Distribution

  • 07899878064411 ()

  • Length: 33 Millimeter
105.171

  • Dental implant system

Neodent - 07899878064404

EASYGUIDE GM REGULAR DRIVER FOR CONTRA-ANGLE
JJGC Indústria e Comércio de Materiais Dentários S/A.
105.170
In Commercial Distribution

  • 07899878064404 ()

  • Length: 33 Millimeter
105.170

  • Dental implant system

Neodent - 07899878064398

EASYGUIDE GM NARROW DRIVER FOR CONTRA-ANGLE
JJGC Indústria e Comércio de Materiais Dentários S/A.
105.169
In Commercial Distribution

  • 07899878064398 ()

  • Length: 33 Millimeter
105.169

  • Dental implant system

Neodent - 07899878064381

GM IMPLANT DRIVER FOR CONTRA-ANGLE
JJGC Indústria e Comércio de Materiais Dentários S/A.
105.168
In Commercial Distribution

  • 07899878064381 ()

  • Length: 28 Millimeter
105.168

  • Dental implant system

HawkOne - 00821684057964

Cutter Driver
Covidien LP
H1-14550
In Commercial Distribution

  • 00821684057964 ()


  • Mechanical atherectomy system catheter, peripheral

Monster Screw System - 00889795016447

Monster BITE, Driver, AO
Paragon 28, Inc.
P24-905-0001
In Commercial Distribution

  • 00889795016447 ()
P24-905-0001

  • Surgical screwdriver, reusable

Shukla Lag S9LAG - B756SSH0560

Shaft, Threaded, 12-28 for Lag Driver
Shukla Medical
SSH056
In Commercial Distribution

  • B756SSH0560 ()


  • Orthopaedic inorganic implant inserter/extractor, single-use

Shukla Lag S9LAG - B756SSH0460

Shaft, Threaded, 10-24 for Lag Driver
Shukla Medical
SSH046
In Commercial Distribution

  • B756SSH0460 ()


  • Orthopaedic implant-instrument extension adaptor, reusable

Shukla Lag S9LAG - B756SSH0450

Shaft, Threaded, 5/16-24 for Lag Driver
Shukla Medical
SSH045
In Commercial Distribution

  • B756SSH0450 ()


  • Orthopaedic implant-instrument extension adaptor, reusable

Shukla Lag S9LAG - B756SSH0440

Shaft, Threaded, 1/4-28 for Lag Driver
Shukla Medical
SSH044
In Commercial Distribution

  • B756SSH0440 ()


  • Orthopaedic implant-instrument extension adaptor, reusable
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