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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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NA - 03596010083029

STEINMANN PIN DIAMOND POINT BOTH ENDS 9/64 X 9
Smith & Nephew, Inc.
128121
In Commercial Distribution

  • 23596010083023 ()
  • 03596010083029 ()
128121

  • Orthopaedic bone pin, non-bioabsorbable

NA - 03596010083012

STEINMANN PIN DIAMOND POINT ROUND END 9/64 X 9
Smith & Nephew, Inc.
128120
In Commercial Distribution

  • 23596010083016 ()
  • 03596010083012 ()
128120

  • Orthopaedic bone pin, non-bioabsorbable

NA - 03596010082992

STEINMANN PIN DIAMOND POINT CHUCK END 9/64 X 9
Smith & Nephew, Inc.
128118
In Commercial Distribution

  • 23596010082996 ()
  • 03596010082992 ()
128118

  • Orthopaedic bone pin, non-bioabsorbable

NA - 03596010082985

STEINMANN PIN TROCAR POINT CHUCK END 9/64 X 9
Smith & Nephew, Inc.
128117
In Commercial Distribution

  • 23596010082989 ()
  • 03596010082985 ()
128117

  • Orthopaedic bone pin, non-bioabsorbable

NA - 03596010082978

STEINMANN PIN Trocar POINT BOTH ENDS 9/64 X 9
Smith & Nephew, Inc.
128116
In Commercial Distribution

  • 23596010082972 ()
  • 03596010082978 ()
128116

  • Orthopaedic bone pin, non-bioabsorbable

Miltex® - 10381780031765

Miltex® Steinmann Pin, 9/64*9"Smooth, Double Trocar
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
270508
In Commercial Distribution

  • H8342705080 ()
  • 10381780031765 ()

  • 9/64 in X 9 in
270508

  • Orthopaedic bone pin, non-bioabsorbable

NaviAid™ SPARKC - 07290018671504

The G-EYE® System comprises the G-EYE® Colonoscope and the NaviAid™ SPARKC (also "SPARKC") air control system which controls inflation and deflation of the G-EYE® balloon. The G-EYE® balloon is inflated using ambient air and controlled by the SPARKC via a foot pedal or a remote panel.
SMART MEDICAL SYSTEMS LTD
SPARKC
In Commercial Distribution

  • 07290018671504 ()
40-016

  • Catheter/overtube balloon inflator, reusable

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

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

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(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

OSS(TM) - 00880304347182

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

  • 00880304347182 ()

  • 9 CM
32-472096

  • Knee femur prosthesis trial, reusable

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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