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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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Silicone T-Tube - 00684995510012

6 Fr. x 12 in L
BENTEC MEDICAL OPCO, LLC
SU130-1216
In Commercial Distribution

  • 00684995510012 ()


  • Biliary drain

Silicone T-Tube - 00684995510005

4 Fr. x 12 in L
BENTEC MEDICAL OPCO, LLC
SU130-1208
In Commercial Distribution

  • 00684995510005 ()


  • Biliary drain

Bard® T-Tube - 00801741018749

Whelan-Moss T-Tubes
C. R. Bard, Inc.
0103250
In Commercial Distribution

  • 10801741018746 ()
  • 00801741018749 ()
0103250

  • Biliary drain

Bard® T-Tube - 00801741018732

Whelan-Moss T-Tubes
C. R. Bard, Inc.
0103240
In Commercial Distribution

  • 10801741018739 ()
  • 00801741018732 ()
0103240

  • Biliary drain

Bard® T-Tube - 00801741018725

Whelan-Moss T-Tubes
C. R. Bard, Inc.
0103230
In Commercial Distribution

  • 10801741018722 ()
  • 00801741018725 ()
0103230

  • Biliary drain

Bard® T-Tube - 00801741018718

Whelan-Moss T-Tubes
C. R. Bard, Inc.
0103220
In Commercial Distribution

  • 10801741018715 ()
  • 00801741018718 ()
0103220

  • Biliary drain

BOSS Instruments - 00888515062986

Adson Tiss Fcps, 1x2 tth, std ptt, 4 3/4"
BOSS INSTRUMENTS, LTD., INC.
510-6475
In Commercial Distribution

  • 00888515062986 ()
510-6475

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

ROTEM® - 04260160470372

The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses. Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected.
Tem Innovations GmbH
sigma
In Commercial Distribution

  • 04260160470372 ()
211000

  • Coagulation analyser IVD, laboratory

Qstat Control Level 2 - 00850003761398

For Use with the QUANTRA® Hemostasis Analyzer
HEMOSONICS, LLC
QStat Control Level 2 Kit (Box of 4)
In Commercial Distribution

  • 00850003761398 ()


  • Coagulation analyser IVD, laboratory

Qstat Control Level 1 - 00850003761336

For Use with the QUANTRA® Hemostasis Analyzer
HEMOSONICS, LLC
QStat Control Level 1 Kit (Box of 4)
In Commercial Distribution

  • 00850003761336 ()


  • Coagulation analyser IVD, laboratory
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