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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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Made-To-Order - 00846832095926

Revive Proximal Broach
TORNIER, INC.
9027272
In Commercial Distribution

  • 00846832095926 ()

  • Size: 9
9027272

  • Orthopaedic fixation plate tensioner

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

U2™ Knee - 04719872177531

Gap gauge, 9/11mm
UNITED ORTHOPEDIC CORP.
9404-7009
In Commercial Distribution

  • 04719872177531 ()

  • 9/11mm
9404-7009

  • Surgical implant template, reusable

U2™ Knee - 04719872174899

Femoral IM rod, 9×400mm
UNITED ORTHOPEDIC CORP.
9303-3210
In Commercial Distribution

  • 04719872174899 ()

  • 9×400mm
9303-3210

  • Orthopaedic implant/instrument assembling device

U2™ Knee - 04719872174554

Femoral IM alignment guide, 9°, right
UNITED ORTHOPEDIC CORP.
9303-2349
In Commercial Distribution

  • 04719872174554 ()

  • 9°, right
9303-2349

  • Orthopaedic fixation implant alignment tool

U2™ Knee - 04719872174493

Femoral IM alignment guide, 9°, left
UNITED ORTHOPEDIC CORP.
9303-2339
In Commercial Distribution

  • 04719872174493 ()

  • 9°, left
9303-2339

  • Orthopaedic fixation implant alignment tool

U2™ Knee - 04719872174400

Femoral IM alignment guide , 9°, left
UNITED ORTHOPEDIC CORP.
9303-2319
In Commercial Distribution

  • 04719872174400 ()

  • 9°, left
9303-2319

  • Orthopaedic fixation implant alignment tool

U2™ Knee - 04719872174349

Femoral IM alignment guide , 9°, right
UNITED ORTHOPEDIC CORP.
9303-2309
In Commercial Distribution

  • 04719872174349 ()

  • 9°, right
9303-2309

  • Orthopaedic fixation implant alignment tool

UTF™ Stem - 04719872167525

UTF Broach, reduced, #9
UNITED ORTHOPEDIC CORP.
9106-6309
In Commercial Distribution

  • 04719872167525 ()

  • reduced, #9
9106-6309

  • Orthopaedic broach

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

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

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

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

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

Singer Laryngectomy Tube - 14063107101943

Size: Size 9 x 55 mm
Boston Medical Products, Inc.
SLT-0955
In Commercial Distribution

  • 34063107101947 ()
  • 14063107101943 ()

  • Size: 9
  • Length: 55 Millimeter
  • Lumen/Inner Diameter: 10.5 Millimeter
  • Outer Diameter: 13.5 Millimeter
SLT-0955

  • Laryngectomy tube

Singer Laryngectomy Tube - 14063107101936

Size: Size 9 x 36 mm
Boston Medical Products, Inc.
SLT-0936
In Commercial Distribution

  • 34063107101930 ()
  • 14063107101936 ()

  • Outer Diameter: 13.5 Millimeter
  • Lumen/Inner Diameter: 10.5 Millimeter
  • Length: 36 Millimeter
  • Size: 9
SLT-0936

  • Laryngectomy tube

Singer Laryngectomy Tube - 14063107101929

Size: Size 9 x 27 mm
Boston Medical Products, Inc.
SLT-0927
In Commercial Distribution

  • 34063107101923 ()
  • 14063107101929 ()

  • Size: 9
  • Length: 27 Millimeter
  • Lumen/Inner Diameter: 10.5 Millimeter
  • Outer Diameter: 13.5 Millimeter
SLT-0927

  • Laryngectomy tube

Singer Laryngectomy Tube - 14063107101912

Size: Size 9 x 18 mm
Boston Medical Products, Inc.
SLT-0918
In Commercial Distribution

  • 34063107101916 ()
  • 14063107101912 ()

  • Outer Diameter: 13.5 Millimeter
  • Lumen/Inner Diameter: 10.5 Millimeter
  • Length: 18 Millimeter
  • Size: 9
SLT-0918

  • Laryngectomy tube

CEMENTED HIP SYSTEM - 00880304004016

No Description
Biomet Orthopedics, LLC
162909
In Commercial Distribution

  • 00880304004016 ()

  • 9 MM
162909

  • Orthopaedic cement spacer

OSS™ Orthopedic Salvage System - 00880304239883

No Description
Biomet Orthopedics, LLC
150467
In Commercial Distribution

  • 00880304239883 ()

  • 9 CM
150467

  • Diaphysis prosthesis

GENERATION 4 HIP SYSTEM - 00880304253537

No Description
Biomet Orthopedics, LLC
162781
In Commercial Distribution

  • 00880304253537 ()

  • 9 SIZE
162781

  • Orthopaedic cement spacer

ANSWER / IMPACT / INTEGRAL HIP SYSTEM - 00880304253162

No Description
Biomet Orthopedics, LLC
162656
In Commercial Distribution

  • 00880304253162 ()

  • 9 SIZE
162656

  • Orthopaedic cement spacer

Klassic Blade Femoral Broach - 00819251020411

Blade Femoral Broach, size 9
TOTAL JOINT ORTHOPEDICS, INC.
1109.09.000
In Commercial Distribution

  • 00819251020411 ()

  • size 9


  • Orthopaedic broach

Klassic HD Modular Femoral Broach - 00819251020305

Modular Femoral Broach, size 9
TOTAL JOINT ORTHOPEDICS, INC.
1106.09.000
In Commercial Distribution

  • 00819251020305 ()

  • size 9


  • Orthopaedic broach

Femoral Broach - 00819251020107

Femoral Broach, Size 9
TOTAL JOINT ORTHOPEDICS, INC.
1100.09.000
In Commercial Distribution

  • 00819251020107 ()

  • Size 9


  • Orthopaedic broach

OSS™ Orthopedic Salvage System - 00880304674929

No Description
Biomet Orthopedics, LLC
151840
In Commercial Distribution

  • 00880304674929 ()

  • 9 CM
151840

  • Diaphysis prosthesis

Cambria - 10889981092931

Cambria Inserter, 9 in
Seaspine Orthopedics Corporation
93-9006
In Commercial Distribution

  • 10889981092931 ()

  • 9 in
93-9006

  • Orthopaedic inorganic implant inserter/extractor, reusable

OSS - 00880304347755

No Description
Biomet Orthopedics, LLC
32-472684
In Commercial Distribution

  • 00880304347755 ()

  • 9 CM
32-472684

  • Orthopaedic implant/instrument dismantling device

OSS - 00880304347366

No Description
Biomet Orthopedics, LLC
32-472639
In Commercial Distribution

  • 00880304347366 ()

  • 9 MM
32-472639

  • Bone-resection orthopaedic reamer, reusable

OSS(TM) - 00880304347571

No Description
Biomet Orthopedics, LLC
32-472666
In Commercial Distribution

  • 00880304347571 ()

  • 9 MM
32-472666

  • Medullary canal orthopaedic reamer, rigid

OSS(TM) - 00880304347182

No Description
Biomet Orthopedics, LLC
32-472096
In Commercial Distribution

  • 00880304347182 ()

  • 9 CM
32-472096

  • Knee femur prosthesis trial, reusable

Oxford Uni Knee System - 00880304525412

No Description
Biomet Uk Ltd
32-422804
In Commercial Distribution

  • 00880304525412 ()

  • Size 9
32-422804

  • Abdominal/ENT/orthopaedic surgical probe, reusable

TUNNELOC - 00880304516748

No Description
Biomet Sports Medicine, LLC
906513
In Commercial Distribution

  • 00880304516748 ()

  • 9 MM
906513

  • Tendon/ligament bone anchor, non-bioabsorbable

MAESTRO TOTAL WRIST - 00880304439108

No Description
Biomet Orthopedics, LLC
180152
In Commercial Distribution

  • 00880304439108 ()

  • 9 MM
180152

  • Total wrist radius prosthesis
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