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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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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

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

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

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

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

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

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

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)

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)

OSS - 00880304347755

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

  • 00880304347755 ()

  • 9 CM
32-472684

  • Orthopaedic implant/instrument dismantling device

OSS(TM) - 00880304347571

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

  • 00880304347571 ()

  • 9 MM
32-472666

  • Medullary canal orthopaedic reamer, rigid

OSS - 00880304347366

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

  • 00880304347366 ()

  • 9 MM
32-472639

  • Bone-resection orthopaedic reamer, reusable

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(TM) - 00880304347182

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

  • 00880304347182 ()

  • 9 CM
32-472096

  • Knee femur prosthesis trial, reusable

OSS™ Orthopedic Salvage System - 00880304239883

No Description
Biomet Orthopedics, LLC
150467
In Commercial Distribution

  • 00880304239883 ()

  • 9 CM
150467

  • Diaphysis prosthesis
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