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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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Long Hex Driver - 00816950028403

Long Hex Driver
Osteocentric Technologies, Inc.
110104
In Commercial Distribution

  • 00816950028403 ()
110104

  • Surgical screwdriver, reusable

2.5mm Hex Driver w/AO Adapter - 00816950028229

2.5mm Hex Driver w/AO Adapter
Osteocentric Technologies, Inc.
110103
In Commercial Distribution

  • 00816950028229 ()

  • Outer Diameter: 2.5 Millimeter
110103

  • Surgical screwdriver, reusable

3.5mm Hex Driver, AO - 00816950028113

3.5mm Hex Driver, AO
Osteocentric Technologies, Inc.
120010
In Commercial Distribution

  • 00816950028113 ()

  • Outer Diameter: 3.5 Millimeter
120010

  • Surgical screwdriver, reusable

T-Handle, Hudson-Mod - 00816950027932

T-Handle, Hudson-Mod
Osteocentric Technologies, Inc.
2004-0009
In Commercial Distribution

  • 00816950027932 ()
2004-0009

  • Orthopaedic implant driver

5.0mm Drill, Cann, Hudson-Mod, 300mm - 00816950027925

5.0mm Drill, Cann, Hudson-Mod, 300mm
Osteocentric Technologies, Inc.
2004-0008
In Commercial Distribution

  • 00816950027925 ()

  • Length: 300 Millimeter
2004-0008

  • Cannulated surgical drill bit, single-use, non-sterile

4.0mm Hex Driver, Solid, Hudson-Mod, 235mm - 00816950027901

4.0mm Hex Driver, Solid, Hudson-Mod, 235mm
Osteocentric Technologies, Inc.
2004-0006
In Commercial Distribution

  • 00816950027901 ()

  • Length: 235 Millimeter
  • 4.0mm Hex
2004-0006

  • Surgical screwdriver, reusable

4.0mm Hex Driver, Cann, Hudson-Mod, 235mm - 00816950027895

4.0mm Hex Driver, Cann, Hudson-Mod, 235mm
Osteocentric Technologies, Inc.
2004-0005
In Commercial Distribution

  • 00816950027895 ()

  • Length: 235 Millimeter
  • 4.0mm Hex
2004-0005

  • Surgical screwdriver, reusable

SIGMA - 10603295083290

SIGMA HP PARTIAL KNEE FEMORAL INTRODUCER
DEPUY ORTHOPAEDICS, INC.
2024-56-000
In Commercial Distribution

  • 10603295083290 ()
202456000

  • Orthopaedic inorganic implant inserter/extractor, reusable

ENDURANCE - 10603295082521

ENDURANCE CUP IMPACTOR TIP
DEPUY ORTHOPAEDICS, INC.
2020-41-000
In Commercial Distribution

  • 10603295082521 ()
202041000

  • Orthopaedic inorganic implant inserter/extractor, reusable

ENDURANCE - 10603295082514

ENDURANCE ALL POLY CUP IMPACTOR/ALIGNMENT GDE
DEPUY ORTHOPAEDICS, INC.
2020-40-000
In Commercial Distribution

  • 10603295082514 ()
202040000

  • Orthopaedic inorganic implant inserter/extractor, reusable

DURALOC - 10603295082392

DURALOC CONST LNR RING STARTER 32mm
DEPUY ORTHOPAEDICS, INC.
2015-19-000
In Commercial Distribution

  • 10603295082392 ()
201519000

  • Orthopaedic inorganic implant inserter/extractor, reusable

DURALOC - 10603295082385

DURALOC CONST LNR RING STARTER 28mm
DEPUY ORTHOPAEDICS, INC.
2015-18-000
In Commercial Distribution

  • 10603295082385 ()
201518000

  • Orthopaedic inorganic implant inserter/extractor, reusable

NA - 10603295079910

REPLACEMENT DELRIN INSERT
DEPUY ORTHOPAEDICS, INC.
2001-12-000
In Commercial Distribution

  • 10603295079910 ()
200112000

  • Orthopaedic prosthesis implantation positioning instrument, reusable

NA - 10603295079903

DRIVER FOR HIP PROSTHESIS
DEPUY ORTHOPAEDICS, INC.
2001-10-000
In Commercial Distribution

  • 10603295079903 ()
200110000

  • Orthopaedic prosthesis implantation positioning instrument, reusable

PATHWAY - 10603295026860

PATHWAY DISASSEMBLY DRIVER
DEPUY INTERNATIONAL LTD
1299-01-030
Not in Commercial Distribution

  • 10603295026860 ()
129901030

  • Orthopaedic implant/instrument dismantling device

CorticaLINK - 00817329024422

Outer Screw Driver Tube
LINKSPINE, INC.
80-4545
In Commercial Distribution

  • 00817329024422 ()
80-4545

  • Surgical screwdriver, reusable

CorticaLINK - 00817329024415

Inner Screw Driver Shaft
LINKSPINE, INC.
80-4544
In Commercial Distribution

  • 00817329024415 ()
80-4544

  • Surgical screwdriver, reusable

CorticaLINK - 00817329024231

Outer Screw Driver Tube
LINKSPINE, INC.
80-4521
In Commercial Distribution

  • 00817329024231 ()
80-4521

  • Surgical screwdriver, reusable

CorticaLINK - 00817329024224

Inner Screwdriver Shaft
LINKSPINE, INC.
80-4520
In Commercial Distribution

  • 00817329024224 ()
80-4520

  • Surgical screwdriver, reusable

CorticaLINK - 00817329024217

Screwdriver Insulating Sleeve
LINKSPINE, INC.
80-4518
In Commercial Distribution

  • 00817329024217 ()
80-4518

  • Surgical screwdriver, reusable

CorticaLINK - 00817329024200

Modular Driver Outer Tube 2 of 2
LINKSPINE, INC.
80-4517
In Commercial Distribution

  • 00817329024200 ()
80-4517

  • Surgical screwdriver, reusable

VertebraLINK - 00817329023968

Mallet
LINKSPINE, INC.
84-0580
In Commercial Distribution

  • 00817329023968 ()
84-0580

  • Surgical mallet

ATTUNE - 10603295451280

ATTUNE KNEE SYSTEM REVISION SYSTEM HEX ATTACHMENT
DEPUY (IRELAND)
2546-00-415
In Commercial Distribution

  • 10603295451280 ()
254600415

  • Surgical screwdriver, reusable

DELTA XTEND - 10603295444794

DELTA XTEND HUMERAL IMPLANT DRIVER
DEPUY (IRELAND)
2307-65-003
In Commercial Distribution

  • 10603295444794 ()
230765003

  • Orthopaedic inorganic implant inserter/extractor, reusable

ATTUNE - 10603295440499

ATTUNE KNEE SYSTEM REVISION FEMORAL SLEEVE TAPER SEPARATOR DRIVER
DEPUY (IRELAND)
2546-00-443
In Commercial Distribution

  • 10603295440499 ()
254600443

  • Orthopaedic inorganic implant inserter/extractor, reusable

ATTUNE - 10603295440376

ATTUNE KNEE SYSTEM REVISION AUGMENT WOBBLE BIT
DEPUY (IRELAND)
2546-00-411
In Commercial Distribution

  • 10603295440376 ()
254600411

  • Surgical screwdriver, reusable

ATTUNE - 10603295440253

ATTUNE KNEE SYSTEM REVISION TIBIAL SLEEVE SEPARATOR - DRIVER
DEPUY (IRELAND)
2546-00-450
In Commercial Distribution

  • 10603295440253 ()
254600450

  • Orthopaedic implant/instrument dismantling device

SIGMA - 10603295436386

SIGMA HP REVISION INSTRUMENTS SCREWDRIVER SHANK 4.5/6.5mm
DEPUY (IRELAND)
2011-03-081
In Commercial Distribution

  • 10603295436386 ()
201103081

  • Surgical screwdriver, reusable

SIGMA - 10603295436379

SIGMA HP REVISION INSTRUMENTS TORQUE LIMITING SCREWDRIVER
DEPUY (IRELAND)
2011-03-080
In Commercial Distribution

  • 10603295436379 ()
201103080

  • Surgical screwdriver, reusable

INHANCE SHOULDER SYSTEM - 10603295560050

INHANCE SHOULDER SYSTEM DRIVER NA NA
DEPUY (IRELAND)
7500-10-106
In Commercial Distribution

  • 10603295560050 ()
750010106

  • Bone-resection orthopaedic reamer, single-use

CORAIL/ TRI-LOCK - 10603295552222

CORAIL/TRI-LOCK MAKE TO ORDER 30-DEG STEM INSERTER
DEPUY ORTHOPAEDICS, INC.
2999-64-877
In Commercial Distribution

  • 10603295552222 ()
299964877

  • Orthopaedic inorganic implant inserter/extractor, reusable

INHANCE SHOULDER SYSTEM - 10603295551768

INHANCE SHOULDER SYSTEM READY-SET GO GENERAL KIT NA NA
DEPUY (IRELAND)
7700-00-100
In Commercial Distribution

  • 10603295551768 ()
770000100

  • Joint prosthesis implantation kit, single-use

Apollo Anterior Cervical Plate System - B521115312010

Apollo Retaining Driver AO Connect Shaft
AURORA SPINE, INC.
115-312-01
In Commercial Distribution

  • B521115312010 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

PINNACLE - 10603295549307

PINNACLE MAKE TO ORDER DUAL OFFSET CUP IMPACTOR DRIVER ASSEMBLY
DEPUY ORTHOPAEDICS, INC.
2999-66-930
In Commercial Distribution

  • 10603295549307 ()
299966930

  • Orthopaedic inorganic implant inserter/extractor, reusable

DELTA XTENDTM - 10603295548935

DELTA XTENDTM MAKE TO ORDER LOCKING AO SCREWDRIVER SHAFT
DEPUY ORTHOPAEDICS, INC.
2999-66-957
In Commercial Distribution

  • 10603295548935 ()
299966957

  • Surgical screwdriver, reusable

INHANCE - 10603295547631

INHANCE SHOULDER SYSTEM STAR DRIVER 20
DEPUY (IRELAND)
6505-10-103
In Commercial Distribution

  • 10603295547631 ()
650510103

  • Surgical screwdriver, reusable

INTUITION - 10603295544661

INTUITION FOR HP PARTIAL FEMORAL INTRODUCER
DEPUY (IRELAND)
2525-50-003
In Commercial Distribution

  • 10603295544661 ()
252550003

  • Orthopaedic inorganic implant inserter/extractor, reusable

INHANCE - 10603295539513

INHANCE SHOULDER SYSTEM ONE STEP PREP GLENOID REAMER - BOWTIE X-Large
DEPUY (IRELAND)
6205-60-060
In Commercial Distribution

  • 10603295539513 ()
620560060

  • Bone-resection orthopaedic reamer, reusable

INHANCE - 10603295539506

INHANCE SHOULDER SYSTEM ONE STEP PREP GLENOID REAMER - BOWTIE LARGE
DEPUY (IRELAND)
6205-60-050
In Commercial Distribution

  • 10603295539506 ()
620560050

  • Bone-resection orthopaedic reamer, reusable

INHANCE - 10603295539490

INHANCE SHOULDER SYSTEM ONE STEP PREP GLENOID REAMER - BOWTIE MEDIUM
DEPUY (IRELAND)
6205-60-040
In Commercial Distribution

  • 10603295539490 ()
620560040

  • Bone-resection orthopaedic reamer, reusable

INHANCE - 10603295539476

INHANCE SHOULDER SYSTEM ONE STEP PREP GLENOID REAMER - BOWTIE X-SMALL
DEPUY (IRELAND)
6205-60-020
In Commercial Distribution

  • 10603295539476 ()
620560020

  • Bone-resection orthopaedic reamer, reusable

INHANCE - 10603295539438

INHANCE SHOULDER SYSTEM DRIVER HANDLE
DEPUY (IRELAND)
6205-10-106
In Commercial Distribution

  • 10603295539438 ()
620510106

  • Surgical instrument handle, non-torque-limiting

INHANCE - 10603295539391

INHANCE SHOULDER SYSTEM STAR DRIVER 30
DEPUY (IRELAND)
6205-10-102
In Commercial Distribution

  • 10603295539391 ()
620510102

  • Surgical screwdriver, reusable

INHANCE - 10603295539346

INHANCE SHOULDER SYSTEM STEM INSERTER
DEPUY (IRELAND)
6201-01-151
In Commercial Distribution

  • 10603295539346 ()
620101151

  • Orthopaedic inorganic implant inserter/extractor, reusable

INHANCE - 10603295538929

INHANCE SHOULDER SYSTEM ONE STEP PREP GLENOID REAMER – CIRCULAR SMALL
DEPUY (IRELAND)
6105-30-030
In Commercial Distribution

  • 10603295538929 ()
610530030

  • Bone-resection orthopaedic reamer, reusable

Sonoma Orthopedic Products, Inc - 00816988013150

No Description
ARTHREX, INC.
3.2mm Cannulated Reamer
Not in Commercial Distribution

  • 00816988013150 ()
CS6132-C

  • Cannulated surgical drill bit, single-use

Sonoma Orthopedic Products, Inc - 00816988013136

No Description
ARTHREX, INC.
Jones Bolt Actuation Driver, Disposable
Not in Commercial Distribution

  • 00816988013136 ()
CS7200

  • General internal orthopaedic fixation system implantation kit

Sonoma Orthopedic Products, Inc. - 00816988013129

No Description
ARTHREX, INC.
4.7mm Proximal Reamer Jones Bolt, Sterile
Not in Commercial Distribution

  • 00816988013129 ()
CS7147-CS

  • Cannulated surgical drill bit, single-use

Sonoma Orthopedic Products, Inc. - 00816988013112

No Description
ARTHREX, INC.
3.2mm Proximal Reamer Jones Bolt, Sterile
Not in Commercial Distribution

  • 00816988013112 ()
CS7132-CS

  • Cannulated surgical drill bit, single-use

Sonoma Orthopedic Products, Inc. - 00816988013105

No Description
ARTHREX, INC.
4.0mm Proximal Reamer Jones Bolt, Sterile
Not in Commercial Distribution

  • 00816988013105 ()
CS7140-CS

  • Cannulated surgical drill bit, single-use
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