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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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CS2 Acetabular System - 00840286855624

UJ Screwdriver, Assembly, 3.5 Hex
Shalby Advanced Technologies, Inc.
1801-0-1350
In Commercial Distribution

  • 00840286855624 ()

  • UJ Screwdriver, Assembly, 3.5 Hex
1801-0-1350

  • Surgical screwdriver, reusable

CS2 Acetabular System - 00840286855617

Straight Hex Screwdriver
Shalby Advanced Technologies, Inc.
1801-0-1340
In Commercial Distribution

  • 00840286855617 ()

  • Straight Hex Screwdriver
1801-0-1340

  • Surgical screwdriver, reusable

Consensus Knee System/Revision Knee System - 00840286855167

Fixation Pin, w/Cut-Out, Ø 3.2mm., 4" Long
Shalby Advanced Technologies, Inc.
2800-1-1432
In Commercial Distribution

  • 00840286855167 ()

  • Fixation Pin, w/Cut-Out, Ø 3.2mm., 4" Long
2800-1-1432

  • Orthopaedic intraoperative positioning pin, reusable

Consensus Knee System/Revision Knee System - 00840286855150

Fixation Pin, w/Cutout, Ø 3.2mm, 3" Long
Shalby Advanced Technologies, Inc.
2800-1-1332
In Commercial Distribution

  • 00840286855150 ()

  • Fixation Pin, w/Cutout, Ø 3.2mm, 3" Long
2800-1-1332

  • Orthopaedic intraoperative positioning pin, reusable

Consensus Knee System/Revision Knee System - 00840286855143

Fixation Pin w/Cutout, Ø 3.2mm, 2" Long
Shalby Advanced Technologies, Inc.
2800-1-1232
In Commercial Distribution

  • 00840286855143 ()

  • Fixation Pin w/Cutout, Ø 3.2mm, 2" Long
2800-1-1232

  • Orthopaedic intraoperative positioning pin, reusable

Consensus Knee System/Revision Knee System - 00840286855136

Fixation Pin, Tri-Face, Ø 3.2mm, 2" Long
Shalby Advanced Technologies, Inc.
2800-0-2232
In Commercial Distribution

  • 00840286855136 ()

  • Fixation Pin, Tri-Face, Ø 3.2mm, 2" Long
2800-0-2232

  • Orthopaedic intraoperative positioning pin, reusable

Consensus Knee System/Revision Knee System - 00840286855068

Fixation Pin, Ø 3.2mm, 4" Long
Shalby Advanced Technologies, Inc.
2800-0-0432
In Commercial Distribution

  • 00840286855068 ()

  • Fixation Pin, Ø 3.2mm, 4" Long
2800-0-0432

  • Orthopaedic intraoperative positioning pin, reusable

Consensus Knee System/Revision Knee System - 00840286855051

Fixation Pin, Ø 3.2mm, 3" Long
Shalby Advanced Technologies, Inc.
2800-0-0332
In Commercial Distribution

  • 00840286855051 ()

  • Fixation Pin, Ø 3.2mm, 3" Long
2800-0-0332

  • Orthopaedic intraoperative positioning pin, reusable

Consensus Knee System/Revision Knee System - 00840286855044

Fixation Pin, Ø 3.2mm, 2" Long
Shalby Advanced Technologies, Inc.
2800-0-0232
In Commercial Distribution

  • 00840286855044 ()

  • Fixation Pin, Ø 3.2mm, 2" Long
2800-0-0232

  • Orthopaedic intraoperative positioning pin, reusable

Marina Medical - 00840306805745

Gerzog Mallet, Diameter 25mm, 250g, 18cm
MARINA MEDICAL INSTRUMENTS, INC.
201-258
In Commercial Distribution

  • 00840306805745 ()
201-258

  • Surgical mallet

Marina Medical - 00840306805738

Marina Nylon/Steel Mallet, 265 grams, 1" OD, 18cm
MARINA MEDICAL INSTRUMENTS, INC.
201-253
In Commercial Distribution

  • 00840306805738 ()
201-253

  • Surgical mallet

Marina Medical - 00840306805721

Marina Mallet With Nylon Caps, 250 grams, 1" OD, 18cm
MARINA MEDICAL INSTRUMENTS, INC.
201-250
In Commercial Distribution

  • 00840306805721 ()
201-250

  • Surgical mallet

CODA™ Anterior Cervical Plate System - 00840298700677

Driver, Threaded
Pioneer Surgical Technology, Inc.
58-202230200
In Commercial Distribution

  • 00840298700677 ()
2022-30-200

  • Surgical screwdriver, reusable

CODA™ Anterior Cervical Plate System - 00840298700660

Driver, Tapered
Pioneer Surgical Technology, Inc.
58-202230100
In Commercial Distribution

  • 00840298700660 ()
2022-30-100

  • Surgical screwdriver, reusable

Tahoe Unicompartmental Knee System - 00840286859950

Fixation Pin, Tri face with Tri Hub, OD 3.2mm, 4" Long
Shalby Advanced Technologies, Inc.
2801-0-3432
In Commercial Distribution

  • 00840286859950 ()

  • Fixation Pin, Tri face with Tri Hub, OD 3.2mm, 4" Long
2801-0-3432

  • Orthopaedic intraoperative positioning pin, reusable

Tahoe Unicompartmental Knee System - 00840286846714

Fixation Pin, Tri-Face with Tri-Hub, OC 3.2mm, 3" Long
Shalby Advanced Technologies, Inc.
2801-0-3332
In Commercial Distribution

  • 00840286846714 ()

  • Fixation Pin, Tri-Face with Tri-Hub, OC 3.2mm, 3" Long
2801-0-3332

  • Orthopaedic intraoperative positioning pin, reusable

Tahoe Unicompartmental Knee System - 00840286846707

Fixation Pin, Tri-Face with Tri-Hub, OC 3.2mm, 2" Long
Shalby Advanced Technologies, Inc.
2801-0-3232
In Commercial Distribution

  • 00840286846707 ()

  • Fixation Pin, Tri-Face with Tri-Hub, OC 3.2mm, 2" Long
2801-0-3232

  • Orthopaedic intraoperative positioning pin, reusable

UniSyn Hip System - 00840286843867

Fixation Pin, Resection Guide, UniSyn
Shalby Advanced Technologies, Inc.
4410-10001-A
In Commercial Distribution

  • 00840286843867 ()

  • Fixation Pin, Resection Guide, UniSyn
4410-10001-A

  • Orthopaedic intraoperative positioning pin, reusable

Revision Knee System - 00840286843010

RKS, Peg Driver, .25 Hex
Shalby Advanced Technologies, Inc.
2970-0-0010
In Commercial Distribution

  • 00840286843010 ()

  • Peg Driver, .25 Hex
2970-0-0010

  • Orthopaedic implant driver

Revision Knee System - 00840286842983

RKS, Ball End Hex Driver, 3mm, SS
Shalby Advanced Technologies, Inc.
2970-0-0026
In Commercial Distribution

  • 00840286842983 ()

  • Ball End Hex Driver, 3mm, SS
2970-0-0026

  • Surgical screwdriver, reusable

Consensus Knee System/Revision Knee System - 00840286842136

Fixation Pin, Tri-Face, Ø 3.2mm, 3" Long
Shalby Advanced Technologies, Inc.
2800-0-2332
In Commercial Distribution

  • 00840286842136 ()

  • Fixation Pin, Tri-Face, Ø 3.2mm, 3" Long
2800-0-2332

  • Orthopaedic intraoperative positioning pin, reusable

Consensus Knee System/Revision Knee System - 00840286842129

Fixation Pin, Tri-Face, Ø 3.2mm, 4" Long
Shalby Advanced Technologies, Inc.
2800-0-2432
In Commercial Distribution

  • 00840286842129 ()

  • Fixation Pin, Tri-Face, Ø 3.2mm, 4" Long
2800-0-2432

  • Orthopaedic intraoperative positioning pin, reusable

NA - 10810030860461

TKR Foot Rest (radiolucent). Assists in supporting legs for total knee replacement procedures. Constructed of stainless steel and polyoxy-methylene for ultimate support. Top portion is radiolucent. 5/8" diameter stainless steel post fits into Clark Socket (sold separately). Includes one single use disposable pad of soft black cushion. Replacement pads available for purchase separately. .
MID CENTRAL MEDICAL CORP.
MCM612
In Commercial Distribution

  • 10810030860461 ()

  • Length: 12 Inch
  • Depth: 2 Inch
  • Height: 16.5 Inch
MCM612

  • Leg procedure positioner

Abutment Removal Tip - 08800011268169

No Description
POINTIMPLANT Co., Ltd.
OSARMTEL
In Commercial Distribution

  • 08800011268169 ()


  • Surgical screwdriver, reusable

Abutment Removal Tip - 08800011268152

No Description
POINTIMPLANT Co., Ltd.
OSARMTL
In Commercial Distribution

  • 08800011268152 ()


  • Surgical screwdriver, reusable

Abutment Removal Tip - 08800011268145

No Description
POINTIMPLANT Co., Ltd.
OSARMTS
In Commercial Distribution

  • 08800011268145 ()


  • Surgical screwdriver, reusable

Abutment Removal Tip - 08800011268138

No Description
POINTIMPLANT Co., Ltd.
OSARTEL
In Commercial Distribution

  • 08800011268138 ()


  • Surgical screwdriver, reusable

Abutment Removal Tip - 08800011268121

No Description
POINTIMPLANT Co., Ltd.
OSARTL
In Commercial Distribution

  • 08800011268121 ()


  • Surgical screwdriver, reusable

Abutment Removal Tip - 08800011268114

No Description
POINTIMPLANT Co., Ltd.
OSARTS
In Commercial Distribution

  • 08800011268114 ()


  • Surgical screwdriver, reusable

Idys™- ALIF - 03700780629978

SELF-RETAINING WRENCH
CLARIANCE
24720005
In Commercial Distribution

  • 03700780629978 ()
24720005

  • Surgical screwdriver, reusable

Erisma®-LP - 03700780629961

SHORT SLEEVE FOR SCREWDRIVER
CLARIANCE
13914009
In Commercial Distribution

  • 03700780629961 ()
13914009

  • Surgical screwdriver, reusable

Erisma®-LP - 03700780629923

QUICK-CONNECT SHAFT
CLARIANCE
13911011
In Commercial Distribution

  • 03700780629923 ()
13911011

  • Surgical screwdriver, reusable

Erisma®-LP - 03700780629916

SCREWDRIVER SHAFT
CLARIANCE
13911012
In Commercial Distribution

  • 03700780629916 ()
13911012

  • Surgical screwdriver, reusable

Erisma®-LP - 03700780629909

SCREWDRIVER BODY
CLARIANCE
18912034
In Commercial Distribution

  • 03700780629909 ()
18912034

  • Surgical screwdriver, reusable

Erisma®-LP - 03700780629893

SCREWDRIVER
CLARIANCE
13710006
In Commercial Distribution

  • 03700780629893 ()
13710006

  • Surgical screwdriver, reusable

Erisma®-LP - 03700780626366

Self retaining set screw driver
CLARIANCE
18720011
In Commercial Distribution

  • 03700780626366 ()
18720011

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Erisma®-LP - 03700780616503

Self retaining set screw driver
CLARIANCE
01720006
In Commercial Distribution

  • 03700780616503 ()
01720006

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Off-Axis Handpiece Tool Long - 10841307127734

No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
HD1.3LB
In Commercial Distribution

  • 10841307127734 ()

  • Diameter: 1.3mmD
HD1.3LB

  • Surgical screwdriver, reusable

Off-Axis Driver Access Plug - 10841307122968

No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
DAP
In Commercial Distribution

  • 10841307122968 ()
DAP

  • Dental implant suprastructure, temporary, preformed, single-use

Off-Axis Handpiece Tool - 10841307122951

No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
HD1.3B
In Commercial Distribution

  • 10841307122951 ()

  • Diameter: 1.3mmD
HD1.3B

  • Surgical screwdriver, reusable

Off-Axis Wrench Tool - 10841307122944

No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
HT1.3B
In Commercial Distribution

  • 10841307122944 ()

  • Diameter: 1.3mmD
HT1.3B

  • Surgical screwdriver, reusable

Off-Axis Wrench Tool Long - 10841307122937

No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
HT1.3LB
In Commercial Distribution

  • 10841307122937 ()

  • Diameter: 1.3mmD
HT1.3LB

  • Surgical screwdriver, reusable

Off-Axis Wrench Tool Short - 10841307122920

No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
HT1.3SB
In Commercial Distribution

  • 10841307122920 ()

  • Diameter: 1.3mmD
HT1.3SB

  • Surgical screwdriver, reusable

Repl. Top O-ring - Wrench Tools - 10841307122319

No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
ORing-60
In Commercial Distribution

  • 10841307122319 ()
ORing-60

  • Surgical screwdriver, reusable

PEEK Replacement O-Ring for 2.7mmD Hex Tools (2 pieces) - 10841307122296

No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
PEEK-2.7
In Commercial Distribution

  • 10841307122296 ()
  • 00841307122299 ()
PEEK-2.7

  • Surgical screwdriver, reusable

PEEK Replacement O-Ring for 2.3mmD Hex Tools (2 pieces) - 10841307122289

No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
PEEK-2.3
In Commercial Distribution

  • 10841307122289 ()
  • 00841307122282 ()
PEEK-2.3

  • Surgical screwdriver, reusable

simplyLegacy™ DRIVER - 10841307119913

No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
HD2.0SG
In Commercial Distribution

  • 10841307119913 ()

  • 2.0mm
HD2.0SG

  • Surgical screwdriver, reusable

simplyLegacy™ DRIVER - 10841307119890

No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
HT3.0LG
In Commercial Distribution

  • 10841307119890 ()

  • 3.0mm
HT3.0LG

  • Surgical screwdriver, reusable

simplyLegacy™ DRIVER - 10841307119852

No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
HT2.5LG
In Commercial Distribution

  • 10841307119852 ()

  • 2.5mm
HT2.5LG

  • Surgical screwdriver, reusable

simplyInterActive® DRIVER - 10841307119838

No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
HT2.3LG
In Commercial Distribution

  • 10841307119838 ()

  • 2.3mm
HT2.3LG

  • Surgical screwdriver, reusable
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