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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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Sterling Medical Products - 00685404001992

Urinary Collection Kit with Catheter
APOLLO MEDICAL PRODUCTS CORP.
UK 6.5
In Commercial Distribution

  • 10685404001999 ()
  • 00685404001992 ()


  • Single-administration urethral catheterization kit, single-use

Sterling Medical Products - 00685404001985

Urinary Collection Kit with Catheter
APOLLO MEDICAL PRODUCTS CORP.
UK 5.0
In Commercial Distribution

  • 10685404001982 ()
  • 00685404001985 ()


  • Single-administration urethral catheterization kit, single-use

IV Start Kit with Nitrile Gloves - 00860008059543

IV Start Kit with Gloves
Dynarex Corporation
4704
In Commercial Distribution

  • 00860008059543 ()


  • Basic intravenous administration set, noninvasive

RELiZORB - 00862205000250

Ezyme Packed Cartridge with ENFit
Alcresta Therapeutics, Inc.
100300/100301
In Commercial Distribution

  • 20862205000230 ()
  • 00862205000250 ()
  • 20862205000254 ()


  • Enteral feed fat-digestion cartridge

RELiZORB - 00862205000212

Enzyme Packed Cartridge with ENFit.
Alcresta Therapeutics, Inc.
200209 / 200211
In Commercial Distribution

  • 00862205000212 ()
  • 00862205000229 ()
  • 00862205000243 ()
  • 00862205000236 ()


  • Enteral feed fat-digestion cartridge

EZ WIDER BARIATRIC BED - 00861525000438

Hospital Bariatric Bed with Drive
KREG MEDICAL INC.
ASM100130
In Commercial Distribution

  • 00861525000438 ()


  • Basic electric hospital bed
  • Bed mattress support platform, electric
  • Bariatric bed

Domico Med-Device, LLC - 00861001002635

Child Hugger with Table Adapter
DOMICO MED-DEVICE, LLC
9013
In Commercial Distribution

  • 00861001002635 ()


  • Multifunction body cushion

ML 830® - 00859626006206

DC Console Adapter with Cord
MICROLIGHT CORPORATION OF AMERICA
ML-830-04-003
In Commercial Distribution

  • 00859626006206 ()
ML-830-04-003

  • Laser adaptor

Generica Medical - 00859261004070

60cc Irrigation Syringe with ENFit
GENERICA MEDICAL INTERNATIONAL
GMI-200FTIS
In Commercial Distribution

  • 20859261004050 ()
  • 00859261004070 ()


  • Irrigation syringe

NA - 00858778006843

Fenestrated Drape with Clear Window
FOOTPRINT MEDICAL, INC.
MAXDRAPE
In Commercial Distribution

  • 00858778006843 ()
  • 10858778006840 ()


  • Patient surgical drape, single-use
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