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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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Galaxy - 08809263397450

PLIF Shaver 9 -062
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809263397450 ()
SCPI-062

  • Bone-screw internal spinal fixation system, non-sterile

Galaxy - 08809263397313

PLIF Distractor 9 -032
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809263397313 ()
SCPI-032

  • Bone-screw internal spinal fixation system, non-sterile

Galaxy - 08809263397221

PLIF Shaver 9 -022
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809263397221 ()
SCPI-022

  • Bone-screw internal spinal fixation system, non-sterile

mytaMed - B351113090

Frazier-Ferguson Suction, 9 Fr
Mytamed, Inc.
1.13.09
Not in Commercial Distribution

  • B351113090 ()
1.13.09

  • Surgical/emergency suction cannula, non-illuminating, reusable

TLX - 00887517730336

TLX Implant, 7x11x40mm 9°
Nuvasive, Inc.
5871409
In Commercial Distribution

  • 00887517730336 ()


  • Metallic spinal interbody fusion cage

TLX - 00887517670687

TLX Implant, 7x11x40mm 9°
Nuvasive, Inc.
1742605
In Commercial Distribution

  • 00887517670687 ()


  • Metallic spinal interbody fusion cage

SureMAX-SA - 00817662025827

AWL GUIDE SIZE 9
ADDITIVE IMPLANTS, LLC
1
In Commercial Distribution

  • 00817662025827 ()
1022-902

  • Metallic spinal interbody fusion cage

SureMAX-SA - 00817662025520

SureMAX-SA — 14° Large 9
ADDITIVE IMPLANTS, LLC
1
In Commercial Distribution

  • 00817662025520 ()
1022-14151809

  • Metallic spinal interbody fusion cage

SureMAX-SA - 00817662025452

SureMAX-SA — 14° Medium 9
ADDITIVE IMPLANTS, LLC
1
In Commercial Distribution

  • 00817662025452 ()
1022-14141609

  • Metallic spinal interbody fusion cage

SureMAX-SA - 00817662025384

SureMAX-SA — 14° Small 9
ADDITIVE IMPLANTS, LLC
1
In Commercial Distribution

  • 00817662025384 ()
1022-14121409

  • Metallic spinal interbody fusion cage

SureMAX-SA - 00817662025247

SureMAX-SA — 10° Large 9
ADDITIVE IMPLANTS, LLC
1
In Commercial Distribution

  • 00817662025247 ()
1022-10151809

  • Metallic spinal interbody fusion cage

SureMAX-SA - 00817662025179

SureMAX-SA — 10° Medium 9
ADDITIVE IMPLANTS, LLC
1
In Commercial Distribution

  • 00817662025179 ()
1022-10141609

  • Metallic spinal interbody fusion cage

SureMAX-SA - 00817662025100

SureMAX-SA — 10° Small 9
ADDITIVE IMPLANTS, LLC
1
In Commercial Distribution

  • 00817662025100 ()
1022-10121409

  • Metallic spinal interbody fusion cage

SureMAX-SA - 00817662024950

SureMAX-SA — 7° Large 9
ADDITIVE IMPLANTS, LLC
1
In Commercial Distribution

  • 00817662024950 ()
1022-07151809

  • Metallic spinal interbody fusion cage

SureMAX-SA - 00817662024875

SureMAX-SA — 7° Medium 9
ADDITIVE IMPLANTS, LLC
1
In Commercial Distribution

  • 00817662024875 ()
1022-07141609

  • Metallic spinal interbody fusion cage

SureMAX-SA - 00817662024790

SureMAX-SA — 7° Small 9
ADDITIVE IMPLANTS, LLC
1
In Commercial Distribution

  • 00817662024790 ()
1022-07121409

  • Metallic spinal interbody fusion cage

ZSFab Cervical Surgical Instrument - 00810136251333

Trial14*16mm,7°-9
Zsfab, Inc.
14160907
In Commercial Distribution

  • 00810136251333 ()

  • Depth: 14 Millimeter
  • Width: 16 Millimeter
  • Height: 9 Millimeter
  • Angle: 7 degree


  • Metallic spinal interbody fusion cage

PRINCETON - 00810158215528

PLASTER SPREADER REDA 9"
Princeton Medical Group, Inc.
31366-23
In Commercial Distribution

  • 00810158215528 ()


  • Cast spreader, reusable

Interbody System Instruments - M6950020000590

Straight Bone Tamp 9"
Tyber Medical LLC
002-000059
In Commercial Distribution

  • M6950020000590 ()
002-000059

  • Metal-polymer composite spinal interbody fusion cage

Interbody System Instruments - M6950020000490

Narrow Bone Tamp 9"
Tyber Medical LLC
002-000049
In Commercial Distribution

  • M6950020000490 ()
002-000049

  • Metal-polymer composite spinal interbody fusion cage

ORTHOMED - B803710718R0

STEIN.PINS.DMD.THR.9" .177"4.5MM
ORTHO-MED, INC.
OM 71-0718R
In Commercial Distribution

  • B8037107183 ()
  • B803710718R0 ()
OM 71-0718R

  • Orthopaedic bone pin, non-bioabsorbable

NEXUS - 00192629410008

NEXUS BROACH SIZE 9
Microport Orthopedics Inc.
NEXBCH09
In Commercial Distribution

  • M684NEXBCH091 ()
  • 00192629410008 ()
NEXBCH09

  • Orthopaedic prosthesis implantation positioning instrument, reusable

NovoHip Total Hip System - 00811382038310

Taper Rasp, Sz 9
Novosource, LLC
1450-0009
In Commercial Distribution

  • 00811382038310 ()

  • Length: 98 Millimeter
1450-0009

  • Joint prosthesis implantation kit, reusable

BioPlex 2200 - 00847865010603

Celiac IgG Calibrator Set,
BIO-RAD LABORATORIES, INC.
6632200
In Commercial Distribution

  • 00847865010603 ()

  • Total Volume: 0.5 Milliliter
  • 9 Vials
6632200

  • Multiple Coeliac disease-associated antibody IVD, calibrator

BioPlex 2200 - 00847865010597

Celiac IgA Calibrator Set
BIO-RAD LABORATORIES, INC.
6632300
In Commercial Distribution

  • 00847865010597 ()

  • 9 Vials
  • Total Volume: 0.5 Milliliter
6632300

  • Multiple Coeliac disease-associated antibody IVD, calibrator

Oxford Uni Knee System - 05019279400966

No Description
Biomet Uk Ltd
32-422819
In Commercial Distribution

  • 05019279400966 ()

  • Size 9
32-422819

  • Abdominal/ENT/orthopaedic surgical probe, reusable

Oxford Uni Knee System - 05019279400744

No Description
Biomet Uk Ltd
32-422814
In Commercial Distribution

  • 05019279400744 ()

  • Size 9
32-422814

  • Abdominal/ENT/orthopaedic surgical probe, reusable

Oxford Uni Knee System - 05019279400553

No Description
Biomet Uk Ltd
32-422809
In Commercial Distribution

  • 05019279400553 ()

  • Size 9
32-422809

  • Abdominal/ENT/orthopaedic surgical probe, reusable

RESTORIS - 00848486008123

Tapered Femoral Stem, Ext Offset Neck, 12/14 Taper
MAKO SURGICAL CORP.
186004-09
In Commercial Distribution

  • 00848486008123 ()

  • Size: 9
186004-09

  • Press-fit femoral stem prosthesis

RESTORIS - 00848486008116

Tapered Femoral Stem, Standard Neck, 12/14 Taper
MAKO SURGICAL CORP.
186003-09
In Commercial Distribution

  • 00848486008116 ()

  • Size: 9
186003-09

  • Press-fit femoral stem prosthesis

Ascend - 00846832024223

HUMERAL DISTAL TRIAL
TORNIER, INC.
SH070209
In Commercial Distribution

  • 00846832024223 ()

  • Size 9
SH070209

  • Humeral stem prosthesis trial, reusable

Ascend - 00846832024148

MONOLITHIC BROACH
TORNIER, INC.
SH070109
In Commercial Distribution

  • 00846832024148 ()

  • Size 9
SH070109

  • Orthopaedic broach

Medtronic Reusable Instruments - 00643169055988

CAM SPREADER TRIAL 3990009 0 DEG 9MM
MEDTRONIC SOFAMOR DANEK, INC.
3990009
In Commercial Distribution

  • 00643169055988 ()

  • Angle: 0.0 degree
  • MM=9


  • Spinal implant trial

Paragon - 09340499024806

Paragon Distal Broach Size 9 - Male (Omni)
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
GM08001-349-09
In Commercial Distribution

  • 09340499024806 ()

  • Size 9
GM08001-349-09

  • Orthopaedic broach

Paragon - 09340499024608

Paragon Broach, Size 9 - Male (OMNI)
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
GM08001-321-09
In Commercial Distribution

  • 09340499024608 ()

  • Size 9
GM08001-321-09

  • Orthopaedic broach

Made-To-Order - 00846832097012

AFR Short Prox Body Trial
TORNIER, INC.
9027385
In Commercial Distribution

  • 00846832097012 ()

  • Size: 9
9027385

  • Orthopaedic fixation plate tensioner

Made-To-Order - 00846832095926

Revive Proximal Broach
TORNIER, INC.
9027272
In Commercial Distribution

  • 00846832095926 ()

  • Size: 9
9027272

  • Orthopaedic fixation plate tensioner

Tornier Perform Humeral System - 00846832086139

Fracture Rasp Metaphysis
TORNIER, INC.
IFX309
In Commercial Distribution

  • 00846832086139 ()

  • Size: 9
IFX309

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Tornier Perform Humeral System - 00846832086023

Fracture Rasp
TORNIER, INC.
IFX209
In Commercial Distribution

  • 00846832086023 ()

  • Size: 9
  • Length: 130 Millimeter
IFX209

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Tornier Perform Humeral System - 00846832086016

Fracture Rasp
TORNIER, INC.
IFX20990
In Commercial Distribution

  • 00846832086016 ()

  • Length: 90 Millimeter
  • Size: 9
IFX20990

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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