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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. - 00811727013903

Reagent for the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only. 1 x 30 ml
POINTE SCIENTIFIC, INC.
13-B7552-R2-30
In Commercial Distribution

  • 00811727013903 ()
13-B7552-R2-30

  • Urea IVD, kit, enzyme spectrophotometry

Pointe Scientific, Inc. - 00811727013897

Reagent for the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only. 1 x 125 ml
POINTE SCIENTIFIC, INC.
13-B7552-R2-125
In Commercial Distribution

  • 00811727013897 ()
13-B7552-R2-125

  • Urea IVD, kit, enzyme spectrophotometry

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

ChloroChek® Chloridometer® Sweat Chloride Analyzer - 03661540304088

The ChloroChek Chloridometer test system is intended for the quantitative in vitro diagnostic determination of chloride in human sweat using the principle of coulometric titration. Sweat chloride measurements are used in the diagnosis of Cystic Fibrosis. It is for use in Clinical Laboratory settings.
ELITECHGROUP INC.
Model 3400
In Commercial Distribution

  • 03661540304088 ()


  • Chloride coulometric titration analyser IVD, semi-automated

N.A. - EFOR129901021

OrthoEasy Fixation Plates Fixation plate with wire in T-shape
Forestadent Bernhard Förster GmbH
1299-0102
In Commercial Distribution

  • EFOR129901021 ()


  • Orthodontic appliance system, bonded

extriCARE - 00879766005471

3600 Pump set with one canister in a box
OAKWELL DISTRIBUTION, INC.
EC3600-E
In Commercial Distribution

  • 10879766005478 ()
  • 00879766005471 ()


  • Multi-purpose low-vacuum suction system

extriCARE - 00879766005464

2400 Pump set with a canister in a box
OAKWELL DISTRIBUTION, INC.
EC2400-E
In Commercial Distribution

  • 10879766005461 ()
  • 00879766005464 ()


  • Multi-purpose low-vacuum suction system

Surgical Direct - B382SD9340861210

Lieberman MicroFinger Nucleus Manipulator, for use in Left Hand
Surgical Direct, Inc.
SD934086121
In Commercial Distribution

  • B382SD9340861210 ()
SD934086121

  • Ocular hook/spatula/manipulator, reusable

OPTICS ONE - 00815384020397

Leica Bonnet Cover 20 in Dia w/68mm Lens
MEDICAL TECHNIQUE, INC.
4708-40
In Commercial Distribution

  • 00815384020410 ()
  • 00815384020403 ()
  • 00815384020397 ()
4708-40

  • Instrument/equipment drape, single-use, sterile
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