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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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Ophthalmic Speculum - 00841668100172

KRATZ WIRE SPECULUM WITH WINGS
KATENA PRODUCTS, INC.
K1-5060
In Commercial Distribution

  • 00841668100172 ()
K1-5060

  • Eyelid speculum, reusable

APEX Spine System - 00193082050183

Large Polyaxial Screwdriver with Tulip-lock
SPINECRAFT, LLC
6000-89-PLG
In Commercial Distribution

  • 00193082050183 ()
6000-89-PLG

  • General internal orthopaedic fixation system implantation kit

AIM MIS - 00193082150210

AIM Rod Introducer with Stopper
SPINECRAFT, LLC
6100-12KSB
In Commercial Distribution

  • 00193082150210 ()
6100-12KSB

  • General internal orthopaedic fixation system implantation kit

CARDINAL HEALTH - 10887488525709

STERILE ENT PACK WITH PREP
Cardinal Health 200, LLC
SEN5WENCED
In Commercial Distribution

  • 50887488525707 ()
  • 10887488525709 ()
SEN5WENCED

  • General surgical procedure kit, non-medicated, single-use

APEX Knee System - 00841690125754

Patella Resection Guide with Offset
Omni Life Science, Inc.
WS-40071
In Commercial Distribution

  • 00841690125754 ()
WS-40071

  • Joint prosthesis implantation kit, reusable

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

CARDINAL HEALTH - 10887488487243

STR SHOULDER WITH POUCH PK
Cardinal Health 200, LLC
SOPOCSPRAD
In Commercial Distribution

  • 50887488487241 ()
  • 10887488487243 ()
SOPOCSPRAD

  • Orthopaedic surgical procedure kit, non-medicated, single-use

A. Titan Instruments - 00841685104092

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

  • 00841685104092 ()


  • Manual dental scaler, reusable

OMNIBotics - 00841690195320

iBlock Sawing Guide with Cutout
Omni Life Science, Inc.
XK-06449
In Commercial Distribution

  • 00841690195320 ()
XK-06449

  • Orthopaedic prosthesis implantation positioning instrument, reusable

N/A - 00193982455095

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

  • 00193982455095 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
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