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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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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

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

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 - 00846832086016

Fracture Rasp
TORNIER, INC.
IFX20990
In Commercial Distribution

  • 00846832086016 ()

  • Length: 90 Millimeter
  • Size: 9
IFX20990

  • 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

Klassic Blade Offset Femoral Stem, Porous, Size 9 - 00814703012372

No Description
TOTAL JOINT ORTHOPEDICS, INC.
3107.09.000
In Commercial Distribution

  • 00814703012372 ()

  • Size 9


  • Press-fit hip femur prosthesis, one-piece

Klassic Blade Femoral Stem, Porous, Size 9 - 00814703012280

No Description
TOTAL JOINT ORTHOPEDICS, INC.
3105.09.000
In Commercial Distribution

  • 00814703012280 ()

  • Size 9


  • Press-fit hip femur prosthesis, one-piece

Klassic HD Hip System Offset Femoral Stem, Porous, size 9 - 00814703011450

No Description
TOTAL JOINT ORTHOPEDICS, INC.
3103.09.000
In Commercial Distribution

  • 00814703011450 ()

  • size 9


  • Press-fit hip femur prosthesis, one-piece

Klassic HD Hip System Femoral Stem (12/14 taper), Porous, size 9 - 00814703010200

No Description
TOTAL JOINT ORTHOPEDICS, INC.
3101.09.000
In Commercial Distribution

  • 00814703010200 ()

  • size 9


  • Press-fit hip femur prosthesis, one-piece

NA - 00889024132108

No Description
Zimmer, Inc.
7712-09-60
In Commercial Distribution

  • 00889024132108 ()

  • Size 9
00-7712-009-60

  • Orthopaedic prosthesis implantation positioning instrument, reusable

NA - 00889024128262

No Description
Zimmer, Inc.
6712-09-02
In Commercial Distribution

  • 00889024128262 ()

  • Size 9
00-6712-009-02

  • Orthopaedic prosthesis implantation positioning instrument, reusable

NA - 00889024128255

No Description
Zimmer, Inc.
6712-09-01
In Commercial Distribution

  • 00889024128255 ()

  • Size 9
00-6712-009-01

  • Orthopaedic prosthesis implantation positioning instrument, reusable

NA - 00889024128026

No Description
Zimmer, Inc.
6711-09-40
In Commercial Distribution

  • 00889024128026 ()

  • Size 9
00-6711-009-40

  • Orthopaedic prosthesis implantation positioning instrument, reusable

NA - 00889024127906

No Description
Zimmer, Inc.
6710-09-02
In Commercial Distribution

  • 00889024127906 ()

  • Size 9
00-6710-009-02

  • Press-fit hip femur prosthesis, modular

NA - 00889024127890

No Description
Zimmer, Inc.
6710-09-01
In Commercial Distribution

  • 00889024127890 ()

  • Size 9
00-6710-009-01

  • Press-fit hip femur prosthesis, modular

VerSys Heritage® - 00889024142039

No Description
Zimmer, Inc.
7894-09-57
In Commercial Distribution

  • 00889024142039 ()

  • Size 9
00-7894-009-57

  • Femoral stem prosthesis trial

VerSys® - 00889024141391

No Description
Zimmer, Inc.
7893-09
In Commercial Distribution

  • 00889024141391 ()

  • Size 9
00-7893-009-00

  • Bone file/rasp, manual, reusable

VerSys® - 00889024140783

No Description
Zimmer, Inc.
7892-09-70
In Commercial Distribution

  • 00889024140783 ()

  • Size 9
00-7892-009-70

  • Orthopaedic prosthesis implantation positioning instrument, reusable

VerSys Heritage® - 00889024140776

No Description
Zimmer, Inc.
7892-09-57
In Commercial Distribution

  • 00889024140776 ()

  • Size 9
00-7892-009-57

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Trabecular Metal® - 00889024139787

No Description
Zimmer, Inc.
00-7865-054-09
In Commercial Distribution

  • 00889024139787 ()

  • Size 9
00-7865-054-09

  • Femoral stem prosthesis trial

Trabecular Metal® - 00889024139411

No Description
Zimmer, Inc.
00-7865-010-09
In Commercial Distribution

  • 00889024139411 ()

  • Size 9
00-7865-010-09

  • Bone-resection orthopaedic reamer, reusable

Trabecular Metal® - 00889024139398

No Description
Zimmer, Inc.
00-7865-009-50
In Commercial Distribution

  • 00889024139398 ()

  • Size 9
00-7865-009-50

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Trabecular Metal® - 00889024139381

No Description
Zimmer, Inc.
00-7865-009-00
In Commercial Distribution

  • 00889024139381 ()

  • Size 9
00-7865-009-00

  • Orthopaedic prosthesis implantation positioning instrument, reusable

NA - 00889024133181

No Description
Zimmer, Inc.
7803-50-09
Not in Commercial Distribution

  • 00889024133181 ()

  • 9 mm


  • Orthopaedic prosthesis implantation positioning instrument, reusable

Kinectiv® - 00889024132764

No Description
Zimmer, Inc.
00-7714-009-00
In Commercial Distribution

  • 00889024132764 ()

  • Size 9
00-7714-009-00

  • Bone file/rasp, manual, reusable

Kinectiv® - 00889024132627

No Description
Zimmer, Inc.
00-7713-009-00
In Commercial Distribution

  • 00889024132627 ()

  • Size 9
00-7713-009-00

  • Press-fit hip femur prosthesis, modular

Instrument - 07613327418446

Specialty Accolade II Broach Trial
Howmedica Osteonics Corp.
I-H2135BT09
In Commercial Distribution

  • 07613327418446 ()

  • Size: 9
I-H2135BT09

  • Orthopaedic broach

Instrument - 07613327519969

Insignia Hip Stem Broach
Howmedica Osteonics Corp.
8000-7709
In Commercial Distribution

  • 07613327519969 ()

  • Size: 9
8000-7709

  • Orthopaedic broach

INSTRUMENT - 07613327260205

TIBIAL PUNCH THRU BASEPLATE
Howmedica Osteonics Corp.
3750-0009-A
In Commercial Distribution

  • 07613327260205 ()

  • Size: 9
3750-0009-A

  • Surgical implant template, reusable

INSTRUMENT - 07613327252606

ACCOLADE II BROACH
Howmedica Osteonics Corp.
1020-5209
In Commercial Distribution

  • 07613327252606 ()

  • Size: 9
1020-5209

  • Orthopaedic broach

INSTRUMENT - 07613327252347

SCORPIO / NRG 4-IN-1 CUTTING BLOCK
Howmedica Osteonics Corp.
8010-2009
In Commercial Distribution

  • 07613327252347 ()

  • Size: 9
8010-2009

  • Orthopaedic prosthesis implantation positioning instrument, reusable

DISTRACTION, INTERNAL - 00888118129161

PLATE, LEFORT 1, ADJ MIDFACE, BUTTRESS, CONE CONNECT, 5 MM AP, 3 MM BRG, TI-6AL-4V
KLS-Martin L.P.
51-401-03-09
In Commercial Distribution

  • 00888118129161 ()

  • 9 HOLE


  • Implantable craniofacial bone distractor

DISTRACTION, INTERNAL - 00888118129154

PLATE, LEFORT 1, ADJ MIDFACE, BUTTRESS, CONE CONNECT, 5 MM AP, 6 MM BRG, TI-6AL-4V
KLS-Martin L.P.
51-401-06-09
In Commercial Distribution

  • 00888118129154 ()

  • 9 HOLE


  • Implantable craniofacial bone distractor

DISTRACTION, INTERNAL - 00888118129147

PLATE, LEFORT 1, ADJ MIDFACE, BUTTRESS, CONE CONNECT, 5 MM AP, 9 MM BRG, TI-6AL-4V
KLS-Martin L.P.
51-401-09-09
In Commercial Distribution

  • 00888118129147 ()

  • 9 HOLE


  • Implantable craniofacial bone distractor

MITCHELL AORTIC VALVE DILATOR - B09927002250

MITCHELL AORTIC VALVE DILATOR
SONTEC INSTRUMENTS, INC.
2700-225
Not in Commercial Distribution

  • B09927002250 ()

  • 25mm 9"


  • Vascular dilator, reusable

MITCHELL AORTIC VALVE DILATOR - B09927002240

MITCHELL AORTIC VALVE DILATOR
SONTEC INSTRUMENTS, INC.
2700-224
Not in Commercial Distribution

  • B09927002240 ()

  • 24mm 9"


  • Vascular dilator, reusable

MITCHELL AORTIC VALVE DILATOR - B09927002230

MITCHELL AORTIC VALVE DILATOR
SONTEC INSTRUMENTS, INC.
2700-223
Not in Commercial Distribution

  • B09927002230 ()

  • 23mm 9"


  • Vascular dilator, reusable

MITCHELL AORTIC VALVE DILATOR - B09927002220

MITCHELL AORTIC VALVE DILATOR
SONTEC INSTRUMENTS, INC.
2700-222
Not in Commercial Distribution

  • B09927002220 ()

  • 22mm 9"


  • Vascular dilator, reusable

MITCHELL AORTIC VALVE DILATOR - B09927002210

MITCHELL AORTIC VALVE DILATOR
SONTEC INSTRUMENTS, INC.
2700-221
Not in Commercial Distribution

  • B09927002210 ()

  • 21mm 9"


  • Vascular dilator, reusable

MITCHELL AORTIC VALVE DILATOR - B09927002200

MITCHELL AORTIC VALVE DILATOR
SONTEC INSTRUMENTS, INC.
2700-220
Not in Commercial Distribution

  • B09927002200 ()

  • 20mm 9"


  • Vascular dilator, reusable

MITCHELL AORTIC VALVE DILATOR - B09927002190

MITCHELL AORTIC VALVE DILATOR
SONTEC INSTRUMENTS, INC.
2700-219
Not in Commercial Distribution

  • B09927002190 ()

  • 19mm 9"


  • Vascular dilator, reusable

MITCHELL AORTIC VALVE DILATOR - B09927002180

MITCHELL AORTIC VALVE DILATOR
SONTEC INSTRUMENTS, INC.
2700-218
Not in Commercial Distribution

  • B09927002180 ()

  • 18mm 9"


  • Vascular dilator, reusable

MITCHELL AORTIC VALVE DILATOR - B09927002170

MITCHELL AORTIC VALVE DILATOR
SONTEC INSTRUMENTS, INC.
2700-217
Not in Commercial Distribution

  • B09927002170 ()

  • 17mm 9"


  • Vascular dilator, reusable

MITCHELL AORTIC VALVE DILATOR - B09927002160

MITCHELL AORTIC VALVE DILATOR
SONTEC INSTRUMENTS, INC.
2700-216
Not in Commercial Distribution

  • B09927002160 ()

  • 16mm 9"


  • Vascular dilator, reusable

MITCHELL AORTIC VALVE DILATOR - B09927002150

MITCHELL AORTIC VALVE DILATOR
SONTEC INSTRUMENTS, INC.
2700-215
Not in Commercial Distribution

  • B09927002150 ()

  • 15mm 9"


  • Vascular dilator, reusable

MITCHELL AORTIC VALVE DILATOR - B09927002140

MITCHELL AORTIC VALVE DILATOR
SONTEC INSTRUMENTS, INC.
2700-214
Not in Commercial Distribution

  • B09927002140 ()

  • 14mm 9"


  • Vascular dilator, reusable

MITCHELL AORTIC VALVE DILATOR - B09927002130

MITCHELL AORTIC VALVE DILATOR
SONTEC INSTRUMENTS, INC.
2700-213
Not in Commercial Distribution

  • B09927002130 ()

  • 13mm 9"


  • Vascular dilator, reusable

MITCHELL AORTIC VALVE DILATOR - B09927002120

MITCHELL AORTIC VALVE DILATOR
SONTEC INSTRUMENTS, INC.
2700-212
Not in Commercial Distribution

  • B09927002120 ()

  • 12mm 9"


  • Vascular dilator, reusable

MITCHELL AORTIC VALVE DILATOR - B09927002110

MITCHELL AORTIC VALVE DILATOR
SONTEC INSTRUMENTS, INC.
2700-211
Not in Commercial Distribution

  • B09927002110 ()

  • 11mm 9"


  • Vascular dilator, reusable
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