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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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Reform Pedicle Screw System - 00840019937351

Instrument Kit 2
PRECISION SPINE, INC.
39-BK-0202
In Commercial Distribution

  • 00840019937351 ()
39-BK-0202

  • Internal spinal fixation procedure kit, reusable

Sklar® - 10649111251054

ELEVATOR BAYONET #2
SKLAR CORPORATION
49-3720
In Commercial Distribution

  • 10649111251054 ()


  • Bone lever/elevator, reusable

OTELO INSTRUMENTATION - 07640178973060

CONDUCTIVE DILATOR 2
SpineArt SA
OTO-IN 32 00-S
In Commercial Distribution

  • 07640178973060 ()
OTO-IN 32 00-S

  • Surgical retraction system, reusable

OTELO INSTRUMENTATION - 07640178972933

Non-Conductive Dilator 2
SpineArt SA
OTO-IN 32 01-N
In Commercial Distribution

  • 07640178972933 ()
OTO-IN 32 01-N

  • Surgical retraction system, reusable

Sklar® - 10649111070013

DE EXPLORER #2
SKLAR CORPORATION
41-452
In Commercial Distribution

  • 10649111070013 ()


  • Dental surgical probe, reusable

Hip Instruments - 07630040748421

Trial Broach # 2
Medacta International SA
01.10.10.019
In Commercial Distribution

  • 07630040748421 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

HIP Instruments - 07630040763561

MasterLoc broach # 2
Medacta International SA
01.39.10.0002
In Commercial Distribution

  • 07630040763561 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

NA - 00889797005173

Instrument Case #2
WRIGHT MEDICAL TECHNOLOGY, INC.
33600520
In Commercial Distribution

  • 00889797005173 ()
33600520

  • Instrument tray, reusable

SAFCO - 00840018600638

Safco Explorer, 2
NORDENT MANUFACTURING INC
102-9850
In Commercial Distribution

  • 00840018600638 ()


  • Dental surgical probe, reusable

N/A - 00822409115099

Broach, Size 2
Ortho Development Corporation
613-0002
In Commercial Distribution

  • 00822409115099 ()


  • Orthopaedic broach
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