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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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No Description
Respironics Novametrix, LLC
00
In Commercial Distribution

  • 30884838075581 ()
  • 00884838075580 ()
8-100337-00

  • Home CPAP unit
No Description
Biomet Orthopedics, LLC
592215
In Commercial Distribution

  • 00880304395527 ()
592215

  • Instrument tray, reusable
Sterilzation Wire Basket for STar(TM) Drive System
FHC, INC.
67-00-7-00299
In Commercial Distribution

  • 00873263002995 ()
67-00-7

  • Neurosurgical micro targeting drive
No Description
PRO-DEX, INC.
APD-SC-001
In Commercial Distribution

  • 00860540000294 ()


  • Device sterilization/disinfection container, reusable
No Description
ALIMED, INC.
71125520
In Commercial Distribution

  • 00733657286076 ()
  • 00733657300307 ()
2970008724

  • Bedpan
An adhesive substance designed to assist patients with retaining their stockings in the prescribed location.
SIGVARIS INC
581I
In Commercial Distribution

  • 00745129164713 ()

  • No Device Sizes
581I300

  • Compression/pressure sock/stocking, single-use
No Description
PRO-DEX, INC.
60.000.015
In Commercial Distribution

  • 00856482008108 ()


  • Device sterilization/disinfection container, reusable
Insulin Pen Needle Sterile Single Use Pen Needle 5,000 pcs per case
HEPRO.US INC.
CT - Insulin Pen Needles
In Commercial Distribution

  • 00854427007940 ()
  • 85442700794002 ()


  • Hypodermic needle, single-use
Material 68gsm A/S Spunlace Includes 2 hand paper towels 30.5 x 34 cm and 1 Wrapper - 40 Sterile Pouch
HEPRO.US INC.
CT - Standard Surgical Gown Spunlace
In Commercial Distribution

  • 00854427007056 ()
  • 85442700705602 ()


  • Surgical gown, single-use
A reusable instrument storage case that can house and retain the reusable instruments of the Removal Tool Set during sterilization processing in preparation for Implant removal.
Curvafix Inc
CIC-005
In Commercial Distribution

  • 10855068008836 ()
CIC-005

  • Device sterilization/disinfection container, reusable
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