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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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Pointe Scientific, Inc. - 00811727013880

Reagent for the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only. 1 x 500 ml
POINTE SCIENTIFIC, INC.
13-B7552-R1-500
In Commercial Distribution

  • 00811727013880 ()
13-B7552-R1-500

  • Urea IVD, kit, enzyme spectrophotometry

Pointe Scientific, Inc. - 00811727013873

Reagent for the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only. 1 x 120 ml
POINTE SCIENTIFIC, INC.
13-B7552-R1-120
In Commercial Distribution

  • 00811727013873 ()
13-B7552-R1-120

  • Urea IVD, kit, enzyme spectrophotometry

Pointe Scientific, Inc. - 00811727011756

Reagent for the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum. 1 x 500ml, 1 x 125ml
POINTE SCIENTIFIC, INC.
L7572-625
In Commercial Distribution

  • 00811727011756 ()
L7572-625

  • Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry

Pointe Scientific, Inc. - 00811727011749

Reagent for the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum. 3 x 120ml, 1 x 90ml
POINTE SCIENTIFIC, INC.
L7572-450
In Commercial Distribution

  • 00811727011749 ()
L7572-450

  • Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry

Pointe Scientific, Inc. - 00811727011732

Reagent for the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum. 1 x 120ml, 1 x 30ml
POINTE SCIENTIFIC, INC.
L7572-150
In Commercial Distribution

  • 00811727011732 ()
L7572-150

  • Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry

Total Bilirubin for the Polychem 180 - 00817439021243

For the quantitative determination of total bilirubin in serum using the Poly-Chem 180 analyzer. For in vitro diagnostic use only.
Medtest Dx, Inc.
TIB505
In Commercial Distribution

  • 00817439021243 ()
TIB505

  • Total bilirubin IVD, kit, spectrophotometry

OmniPro System - B62536083000

The OmniAmp EEG Module is an amplifier system for use in electroencephalogram (EEG) studies in a hospital or diagnostic center.
Mays & Asscoiates
OmniAmp EEG Module
In Commercial Distribution

  • B62536083000 ()

  • Weight: 675 Gram
  • Height: 3.8 Centimeter
  • Width: 15.5 Centimeter
  • Length: 20.5 Centimeter
360-8300

  • Electroencephalograph

Cellfina Motor Module Device and Package - 00840763100384

No change in DI justified in the CO. No form fit function, model or version changes triggering a new DI
Ulthera, Inc.
CM1 Rev C, D, E
In Commercial Distribution

  • 00840763100384 ()


  • Mechanical skin contouring system motor

Medline-Microtek - 10748426140425

Warmer Drape, For use with ORS-2000 Series Fluid Warming System, 132 cm x 168 cm (52 in x 66 in)
Microtek Medical LLC
Fluid Warming - Warmer Drape
In Commercial Distribution

  • 00748426140428 ()
  • 10748426140425 ()
ORS-301N

  • Medical equipment/instrument drape, single-use

Medline-Microtek - 10748426140418

Warmer Drape, For use with ORS-2000 Series Fluid Warming System, 112 cm x 168 cm (44 in x 66 in)
Microtek Medical LLC
Fluid Warming - Warmer Drape
In Commercial Distribution

  • 00748426140411 ()
  • 10748426140418 ()
ORS-300N

  • Medical equipment/instrument drape, single-use
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