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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 L1 - 10859394006078

Abnormal Control L-1 10 x 1 ml
R 2 DIAGNOSTICS, INC.
31-201
In Commercial Distribution

  • 10859394006078 ()
  • 00859394006071 ()
31-201

  • Multiple coagulation factor IVD, control

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

BMT Medizintechnik GmbH - 04251725200053

FORCEPS CANINES #2
BMT Medizintechnik GmbH
2
In Commercial Distribution

  • 04251725200053 ()
2

  • Tooth extraction forceps

Luminary Pink Polymer - D85102

Tinted Glow Powder
JBC and Company
2
In Commercial Distribution

  • D85102 ()
2

  • Dental appliance fabrication material, resin

SDNet Configurable Manual Batch Entry - 00860010612811

Configurable software for managing manually entered blood test results.
Rubin & Poor, Inc.
MBC 1.0B
In Commercial Distribution

  • 00860010612811 ()
2

  • Blood bank information system application software

QuantX - B80721

The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assists users of the QuantX software device in planning MRI guided interventional procedures.
QLARITY IMAGING, LLC
Breast MRI Biopsy Guidance Plugin
In Commercial Distribution

  • B80721 ()
2

  • Radiological PACS software
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