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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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PlasmaCon N - 10859394006061

Normal Control 10 x 1 ml
R 2 DIAGNOSTICS, INC.
30-201
In Commercial Distribution

  • 10859394006061 ()
  • 00859394006064 ()
30-201

  • Multiple coagulation factor IVD, control

T-tek - 10859394006054

Thrombin Time 10 x 1 ml
R 2 DIAGNOSTICS, INC.
50-201
In Commercial Distribution

  • 10859394006054 ()
  • 00859394006057 ()
50-201

  • Thrombin time (TT) IVD, kit, clotting

Phosphoplastin RL - 10859394006030

PT reagent 10 x 10 ml
R 2 DIAGNOSTICS, INC.
11-310
In Commercial Distribution

  • 10859394006030 ()
  • 00859394006033 ()
11-310

  • Prothrombin time (PT) IVD, reagent

Phosphoplastin RL - 10859394006023

PT reagent 10 x 5 ml
R 2 DIAGNOSTICS, INC.
11-305
In Commercial Distribution

  • 10859394006023 ()
  • 00859394006026 ()
11-305

  • Prothrombin time (PT) IVD, reagent

Phospholin ES w/ Calcium Chloride - 10859394006016

APTT reagent 5 x 10 ml with 5 Calcium Chloride
R 2 DIAGNOSTICS, INC.
21-410
In Commercial Distribution

  • 10859394006016 ()
  • 00859394006019 ()
21-410

  • Activated partial thromboplastin time (APTT) IVD, reagent

ThromboTek PSe - 00859394006095

Protein S Kit 80-160 DET
R 2 DIAGNOSTICS, INC.
90-480
In Commercial Distribution

  • 00859394006095 ()
90-480

  • Protein S IVD, kit, clotting

Fibrotek - 00859394006040

Fibrinogen assay 100 DET
R 2 DIAGNOSTICS, INC.
70-410
In Commercial Distribution

  • 00859394006040 ()
70-410

  • Fibrinogen assay (factor I) IVD, kit, clotting

Revive - 00854389008009

The Revive reusable bladder support is intended for temporary management of urinary leakage caused by stress urinary incontinence (SUI) in women, 18 years and older.
RINOVUM SUBSIDIARY 2, LLC
0025
In Commercial Distribution

  • 20854389008027 ()
  • 10854389008020 ()
  • 00854389008023 ()
  • 00854389008009 ()
0025

  • Urinary-incontinence vaginal insert, reusable

Xpect / Temp-N-Toss - 00850053907173

Forehead Thermometers
Cintas Corporation No. 2
619369
In Commercial Distribution

  • 10850053907170 ()
  • 00850053907173 ()


  • Colour-indication patient thermometer

MANI Sutures Silk - 04546951500115

No Description
MANI, INC.
2
In Commercial Distribution

  • 04546951500115 ()
  • 14546951500112 ()
2

  • Silk suture
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