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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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APEX Knee System - 00841690110415

Steinman Pin with Innomed End
Omni Life Science, Inc.
KS-80012
In Commercial Distribution

  • 00841690110415 ()
KS-80012

  • Joint prosthesis implantation kit, reusable

N/A - 00193982455095

Drill with Stop - Liner Removal
GLOBUS MEDICAL, INC.
6235.2001
In Commercial Distribution

  • 00193982455095 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

PICASSO MIS Spinal System - 00841732108950

Hex Driver with Handle, 3.0
CTL Medical Corporation
016.7052
In Commercial Distribution

  • 00841732108950 ()


  • Surgical screwdriver, reusable

RAPHAEL - 00841732108042

Hex Driver with Handle, 5.0
CTL Medical Corporation
015.7081
In Commercial Distribution

  • 00841732108042 ()


  • Internal spinal fixation procedure kit, reusable

DEGAS Anterior Cervical Plate System - 00841732101074

Hex Driver with Handle, 2.35
CTL Medical Corporation
010.7061
In Commercial Distribution

  • 00841732101074 ()
010.7061

  • Spinal fixation plate, non-bioabsorbable

Orthex - 00841731114747

Orthex Strut Diagonal with QC
VILEX IN TENNESSEE, INC.
390-045-Q
In Commercial Distribution

  • 00841731114747 ()


  • External orthopaedic fixation system, single-use

MSI Precision Specialty Instruments - 00194613090357

#3 KNIFE HANDLE WITH RULER
Med Saver, Inc.
01220600ML
In Commercial Distribution

  • 00194613090357 ()


  • Scalpel handle, reusable

Vitality Scanner - 00195062030086

GROUNDING LEAD WITH LIP CLIP
Kerr Corporation
973-0226
In Commercial Distribution

  • 00195062030086 ()


  • Dental pulp analysis system

A. Titan Instruments - 00841685104092

Scaler 1 with #3 handle
A. TITAN INSTRUMENTS, INC.
SCALER 1 3
In Commercial Distribution

  • 00841685104092 ()


  • Manual dental scaler, reusable

Orthex - 00841731112507

Orthex Pin Bolt with washer
VILEX IN TENNESSEE, INC.
C660
In Commercial Distribution

  • 00841731112507 ()
C660

  • External orthopaedic fixation system, single-use
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