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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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Plasma Thawing System
HELMER, INC.
DH2
In Commercial Distribution

  • 00816394020667 ()


  • Cryopreserved blood/tissue thawing unit
Plasma Thawing System
HELMER, INC.
DH8
In Commercial Distribution

  • 00816394020650 ()


  • Cryopreserved blood/tissue thawing unit
Plasma Thawing System
HELMER, INC.
DH4
In Commercial Distribution

  • 00816394020643 ()


  • Cryopreserved blood/tissue thawing unit
Sample Cups: 0.5 ml x 1000
NOVA BIOMEDICAL CORPORATION
Nova
In Commercial Distribution

  • 00385480634120 ()
  • 10385480634127 ()
63412

  • Assay container IVD, single-use
Specimen Infusion Valve (SIV) 0.760 mm ID Metering Line
NICO CORPORATION
NN-8039
In Commercial Distribution

  • 10816744028395 ()
  • 00816744028398 ()


  • Surgical suction system Y-piece valve-connector
Specimen Infusion Valve (SIV) 0.5 mm Metering Line
NICO CORPORATION
NN-8016
In Commercial Distribution

  • 10816744028166 ()
  • 00816744028169 ()


  • Surgical suction system Y-piece valve-connector
No Description
MONOBIND, INC.
IN002
In Commercial Distribution

  • 00816870020044 ()
IN002

  • Microplate washer IVD
The tubes are specimen receptacles for body fluids. The plastic test tubes are 12 mL and contain 500 per package.
BECKMAN COULTER IRELAND INC.
800-3215
In Commercial Distribution

  • 10837461002321 ()
  • 00837461002324 ()
800-3215

  • Assay container IVD, single-use
The tubes are specimen receptacles for urine. The plastic test tubes are 16 x 100 mm and contain 250 per package.
BECKMAN COULTER IRELAND INC.
660-3021
In Commercial Distribution

  • 10837461001065 ()
  • 00837461001068 ()
660-3021

  • Assay container IVD, single-use
Geenius Reader
BIO-RAD
92465
In Commercial Distribution

  • 03610520010785 ()

  • 1 each
92465

  • Photometric/spectroscopic immunoassay analyser IVD
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