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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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Inserter, Hallux Limitus/Dorsal Bunion
Sky Surgical, LLC
001-2-09
In Commercial Distribution

  • 00850024702356 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Inserter, Medial Bunion (Left)
Sky Surgical, LLC
001-2-04-L
In Commercial Distribution

  • 00850024702349 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Headless Compression System 1.5mm Hex Driver Shaft Cannulated
Osteocentric Technologies, Inc.
EX01-0032
In Commercial Distribution

  • 00850015496387 ()
EX01-0032

  • Surgical screwdriver, reusable
Lumbar Interbody Fusion System (OLLIF) Mallet
ADVANCED RESEARCH MEDICAL LLC
01-11
In Commercial Distribution

  • 00850014575489 ()
01-11

  • Surgical mallet
2.5mm Ball Driver
KICO KNEE INNOVATION COMPANY PTY LIMITED
11100
In Commercial Distribution

  • 00850012315124 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
3.5mm Hex Driver
KICO KNEE INNOVATION COMPANY PTY LIMITED
10800
In Commercial Distribution

  • 00850012315117 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
RESOUNDANT, INC.
REFDAUX
In Commercial Distribution

  • 00850011790229 ()


  • Magnetic resonance elastography acoustic driver
No Description
RESOUNDANT, INC.
RESYS4001
In Commercial Distribution

  • 00850011790168 ()


  • Magnetic resonance elastography acoustic driver
No Description
RESOUNDANT, INC.
RESYS4001-RESYSAB
In Commercial Distribution

  • 00850011790151 ()


  • Magnetic resonance elastography acoustic driver
No Description
RESOUNDANT, INC.
REPD2000
In Commercial Distribution

  • 00850011790106 ()


  • Magnetic resonance elastography acoustic driver
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