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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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HistoPro® - B92112691

H&E Slide Stainer, 230V
RUSHABH INSTRUMENTS, LLC
3030, 230V
In Commercial Distribution

  • B92112691 ()
12691

  • Microscope slide stainer IVD

HistoPro® - B92112631

H&E Slide Stainer, 115V
RUSHABH INSTRUMENTS, LLC
3030, 115V
In Commercial Distribution

  • B92112631 ()
12631

  • Microscope slide stainer IVD

Pouresin® - B715351185P0

Pouresin® A/M/E
FRICKE INTERNATIONAL, INC.
3511-85P
In Commercial Distribution

  • B715351185P0 ()

  • Weight: 5 Pound
3511-85P

  • Dental appliance fabrication material, resin

Vitamin A Plus E High - B800100820

Vitamin A Plus E High
UTAK LABORATORIES, INC.
10082
In Commercial Distribution

  • B800100825 ()
  • B800100820 ()

  • Total Volume: 5 Milliliter
10082

  • Multiple vitamin IVD, control

Vitamin A Plus E Low - B800100810

Vitamin A Plus E Low
UTAK LABORATORIES, INC.
10081
In Commercial Distribution

  • B800100815 ()
  • B800100810 ()

  • Total Volume: 5 Milliliter
10081

  • Multiple vitamin IVD, control

Life Instruments - M930780858500

Elevators Howarth D/E 220mm
Life Instrument Corporation
780-8585-0
In Commercial Distribution

  • M930780858500 ()


  • Bone lever/elevator, reusable

Vintage - E23564820

Vintage Opal White E 50g
SHOFU DENTAL CORPORATION
6482
In Commercial Distribution

  • E23564820 ()
6482

  • Dental appliance fabrication material, ceramic

Shiga Toxin Direct Test - B178GBSTEC100

Shiga Toxin Direct Test Cartridge with sample prep device.
GREAT BASIN SCIENTIFIC, INC.
GBSTEC-10
In Commercial Distribution

  • B178GBSTEC102 ()
  • B178GBSTEC100 ()
GBSTEC-10

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

LLD™ E - 00813132020828

Lead Locking Device (LLD™ E)
Spectranetics Corporation
518-039AA
In Commercial Distribution

  • 00813132020828 ()
  • M204518039AA0 ()
  • 20813132020822 ()
518-039

  • Pacing/defibrillation lead stylet, extraction

PATTERSON - D6620705037970

APEX LOCATOR NON E TYPE KIT
PATTERSON DENTAL SUPPLY, INC.
070503797
In Commercial Distribution

  • D6620705037970 ()


  • Endodontic apex locator
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