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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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MAESTRO TOTAL WRIST - 00880304439207

No Description
Biomet Orthopedics, LLC
180153
In Commercial Distribution

  • 00880304439207 ()

  • 9 MM
180153

  • Total wrist radius prosthesis

MAESTRO TOTAL WRIST - 00880304439108

No Description
Biomet Orthopedics, LLC
180152
In Commercial Distribution

  • 00880304439108 ()

  • 9 MM
180152

  • Total wrist radius prosthesis

Disc Prep - 10889981103552

O'Brien Currette, 18" OAL, 9" Handle
Seaspine Orthopedics Corporation
06-40-0408
In Commercial Distribution

  • 10889981103552 ()

  • 18", 9"
06-40-0408

  • Poliovirus total antibody (serotypes PV1-PV3) IVD, kit, complement fixation test (CFT)

Disc Prep - 10889981103545

Ring Currette #4, 18"OAL, 9"Handle
Seaspine Orthopedics Corporation
06-40-0354
In Commercial Distribution

  • 10889981103545 ()

  • 18", 9"
06-40-0354

  • Poliovirus total antibody (serotypes PV1-PV3) IVD, kit, complement fixation test (CFT)

Disc Prep - 10889981103538

Ring Currette #2, 18"OAL, 9" Handle
Seaspine Orthopedics Corporation
06-40-0352
In Commercial Distribution

  • 10889981103538 ()

  • 18", 9"
06-40-0352

  • Poliovirus total antibody (serotypes PV1-PV3) IVD, kit, complement fixation test (CFT)

Disc Prep - 10889981103569

O'Brien Currette, 18"OAL,9"Handle
Seaspine Orthopedics Corporation
06-40-0411
In Commercial Distribution

  • 10889981103569 ()

  • 18", 9"
06-40-0411

  • Poliovirus total antibody (serotypes PV1-PV3) IVD, kit, complement fixation test (CFT)

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

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

OSS™ Orthopedic Salvage System - 00880304239883

No Description
Biomet Orthopedics, LLC
150467
In Commercial Distribution

  • 00880304239883 ()

  • 9 CM
150467

  • Diaphysis prosthesis

CEMENTED HIP SYSTEM - 00880304004016

No Description
Biomet Orthopedics, LLC
162909
In Commercial Distribution

  • 00880304004016 ()

  • 9 MM
162909

  • Orthopaedic cement spacer

ORTHOPEDIC SALVAGE SYSTEM (OSS) - 00880304030763

No Description
Biomet Orthopedics, LLC
CP111279
In Commercial Distribution

  • 00880304030763 ()

  • 9 CM
CP111279

  • Diaphysis prosthesis

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
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