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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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ACL TOP 700 - 08426950497974

ACL TOP 700
INSTRUMENTATION LABORATORY COMPANY
00000280010
In Commercial Distribution

  • 08426950497974 ()
00000280010

  • Coagulation analyser IVD, laboratory

ACL AcuStar cuvettes (1400 pcs) - 08426950497059

ACL AcuStar cuvettes (1400 pcs)
INSTRUMENTATION LABORATORY COMPANY
0009801100
In Commercial Distribution

  • 08426950497059 ()
  • 18426950497056 ()
0009801100

  • Coagulation analyser IVD, laboratory

ACL TOP 500 CTS - 08426950453499

ACL TOP 500 CTS
INSTRUMENTATION LABORATORY COMPANY
00000280040
In Commercial Distribution

  • 08426950453499 ()
00000280040

  • Coagulation analyser IVD, laboratory

ACL ELITE PRO - 08426950453482

ACL ELITE PRO (Refurbished)
INSTRUMENTATION LABORATORY COMPANY
00001000311R
In Commercial Distribution

  • 08426950453482 ()
00001000311R

  • Coagulation analyser IVD, laboratory

Cuvettes (2400 cuvettes) - 08426950075899

Cuvettes (2400 cuvettes)
INSTRUMENTATION LABORATORY COMPANY
00029400100
In Commercial Distribution

  • 08426950075899 ()
  • 18426950075896 ()
00029400100

  • Coagulation analyser IVD, laboratory

Rotors 100 pcs 2000 wells - 08426950003151

Rotors 100 pcs 2000 wells
INSTRUMENTATION LABORATORY COMPANY
00006800000
In Commercial Distribution

  • 08426950003151 ()
  • 18426950003158 ()
00006800000

  • Coagulation analyser IVD, laboratory

ACL TOP 770 LAS - 00195226000535

ACL TOP 770 LAS
INSTRUMENTATION LABORATORY COMPANY
00000280037
In Commercial Distribution

  • 00195226000535 ()
00000280037

  • Coagulation analyser IVD, laboratory

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

ACL TOP 370 - 00195226000566

ACL TOP 370
INSTRUMENTATION LABORATORY COMPANY
00000280067
In Commercial Distribution

  • 00195226000566 ()
00000280067

  • Coagulation analyser IVD, laboratory

ACL TOP 570 - 00195226000559

ACL TOP 570
INSTRUMENTATION LABORATORY COMPANY
00000280047
In Commercial Distribution

  • 00195226000559 ()
00000280047

  • Coagulation analyser IVD, laboratory

ACL TOP 770s - 00195226000542

ACL TOP 770s
INSTRUMENTATION LABORATORY COMPANY
00000280017
In Commercial Distribution

  • 00195226000542 ()
00000280017

  • Coagulation analyser IVD, laboratory

ACL TOP 770 - 00195226000528

ACL TOP 770
INSTRUMENTATION LABORATORY COMPANY
00000280057
In Commercial Distribution

  • 00195226000528 ()
00000280057

  • Coagulation analyser IVD, laboratory

BCS® System Cuvette Rotors - 00842768014444

The BCS Cuvette Rotor is part of the BCS-XP system.
Siemens Healthcare Diagnostics Products GmbH
10446524
In Commercial Distribution

  • 00842768014444 ()
  • 00842768024603 ()
OVIP15

  • Coagulation analyser IVD, laboratory

Behring Coagulation Cup - 00842768012198

Behring Coagulation Cup serves as vessel for samples, human plasma and buffer solutions.
Siemens Healthcare Diagnostics Products GmbH
10446526
In Commercial Distribution

  • 00842768012198 ()
  • 00842768024757 ()
OVIS31

  • Coagulation analyser IVD, laboratory

TEG5000 - 10812747018456

ELECTRONIC PIPPETTE KIT, 1000UL
HAEMONETICS CORPORATION
01-197
In Commercial Distribution

  • 10812747018456 ()

  • Total Volume: 1000 Microliter


  • Coagulation analyser IVD, laboratory

TEG5000 - 10812747018159

PIPETTE KIT, 1000UL
HAEMONETICS CORPORATION
01-097
In Commercial Distribution

  • 10812747018159 ()

  • Total Volume: 1000 Milliliter


  • Coagulation analyser IVD, laboratory

TEG5000 - 10812747018142

PIPETTE KIT, 100UL
HAEMONETICS CORPORATION
01-096
In Commercial Distribution

  • 10812747018142 ()

  • Total Volume: 100 Microliter


  • Coagulation analyser IVD, laboratory

QStat Cartridge - 10850003761180

For Use with the QUANTRA® Hemostasis Analyzer
HEMOSONICS, LLC
QStat Cartridge KIT (Box of 10)
In Commercial Distribution

  • 00850003761183 ()
  • 10850003761180 ()


  • Coagulation analyser IVD, laboratory

Helena Electronic Clotting Tube - M525XLECT10

No Description
HELENA LABORATORIES CORPORATION
XL-ECT1
In Commercial Distribution

  • M525XLECT10 ()


  • Coagulation analyser IVD, laboratory

Actalyke XL, (CSA/CE), W/ Flash Memory - M52557700040

No Description
HELENA LABORATORIES CORPORATION
5770004
In Commercial Distribution

  • M52557700040 ()


  • Coagulation analyser IVD, laboratory

Actalyke XL, (CSA/CE), New Display #2 (110V/220V) - M52557700030

No Description
HELENA LABORATORIES CORPORATION
5770003
In Commercial Distribution

  • M52557700030 ()


  • Coagulation analyser IVD, laboratory

Actalyke XL, Dual Detection, (Display #2) "CE" (110V/220V) - M52557700020

No Description
HELENA LABORATORIES CORPORATION
5770002
In Commercial Distribution

  • M52557700020 ()


  • Coagulation analyser IVD, laboratory

Actalyke XL, Dual Detection, (New Display) "CE" (110V/220V) - M52557700010

No Description
HELENA LABORATORIES CORPORATION
5770001
In Commercial Distribution

  • M52557700010 ()


  • Coagulation analyser IVD, laboratory

Actalyke Thermometer - M52557570000

No Description
HELENA LABORATORIES CORPORATION
5757000
In Commercial Distribution

  • M52557570000 ()


  • Coagulation analyser IVD, laboratory

Actalyke Mini II, w/o Printer & Battery, "CE 2009" (110V/220V) - M52557550010

No Description
HELENA LABORATORIES CORPORATION
5755001
In Commercial Distribution

  • M52557550010 ()


  • Coagulation analyser IVD, laboratory

Actalyke Mini II, w/o Printer & Battery., "CE" (110V/220V) - M52557550000

No Description
HELENA LABORATORIES CORPORATION
5755000
In Commercial Distribution

  • M52557550000 ()


  • Coagulation analyser IVD, laboratory

Actalyke Mini II, w/ Printer, w/o Battery, "CE 2009" (110V/220V) - M52557530010

No Description
HELENA LABORATORIES CORPORATION
5753001
In Commercial Distribution

  • M52557530010 ()


  • Coagulation analyser IVD, laboratory

Actalyke Mini II, w/ Printer, w/o Battery, "CE" (110V/220V) - M52557530000

No Description
HELENA LABORATORIES CORPORATION
5753000
In Commercial Distribution

  • M52557530000 ()


  • Coagulation analyser IVD, laboratory

Cascade M-4 (110V/220V) - M52517110000

No Description
HELENA LABORATORIES CORPORATION
1711000
In Commercial Distribution

  • M52517110000 ()


  • Coagulation analyser IVD, laboratory

STA R Max® (with cap piercing option) - 03607450590272

No Description
DIAGNOSTICA STAGO
59027
In Commercial Distribution

  • 03607450590272 ()


  • Coagulation analyser IVD, laboratory

STA R Max® - 03607450590265

No Description
DIAGNOSTICA STAGO
59026
In Commercial Distribution

  • 03607450590265 ()


  • Coagulation analyser IVD, laboratory

STA R Max® - 03607450590135

No Description
DIAGNOSTICA STAGO
59013
In Commercial Distribution

  • 03607450590135 ()


  • Coagulation analyser IVD, laboratory

STA R Max® (with cap piercing option) - 03607450590104

No Description
DIAGNOSTICA STAGO
59010
In Commercial Distribution

  • 03607450590104 ()


  • Coagulation analyser IVD, laboratory

STA Compact Max® - 03607450589900

No Description
DIAGNOSTICA STAGO
58990
In Commercial Distribution

  • 03607450589900 ()


  • Coagulation analyser IVD, laboratory

STA Compact Max® (with cap piercing option) - 03607450589894

No Description
DIAGNOSTICA STAGO
58989
In Commercial Distribution

  • 03607450589894 ()


  • Coagulation analyser IVD, laboratory

STA-R Evolution® Expert Series (with cap piercing option) - 03607450589795

No Description
DIAGNOSTICA STAGO
58979
In Commercial Distribution

  • 03607450589795 ()


  • Coagulation analyser IVD, laboratory

STA-R Evolution® Expert Series - 03607450589788

No Description
DIAGNOSTICA STAGO
58978
In Commercial Distribution

  • 03607450589788 ()


  • Coagulation analyser IVD, laboratory

STA Satellite® - 03607450581041

No Description
DIAGNOSTICA STAGO
58104
In Commercial Distribution

  • 03607450581041 ()


  • Coagulation analyser IVD, laboratory

TEG6s HEMOSTASIS SYSTEM - 30812747018351

TEG 6S UNIT PACK
HAEMONETICS CORPORATION
07-690-US
In Commercial Distribution

  • 30812747018351 ()


  • Coagulation analyser IVD, laboratory

TEG5000 HEMOSTASIS SYSTEM - 20812747018132

DISPOSABLE CUPS & PINS, CLEAR
HAEMONETICS CORPORATION
6211
In Commercial Distribution

  • 20812747018132 ()


  • Coagulation analyser IVD, laboratory

Supinator PTT Stabilizer - 00802357642663

No Description
MEDICAL SPECIALTIES INCORPORATED
264266
In Commercial Distribution

  • 00802357642663 ()


  • Ankle/foot orthosis

Supinator PTT Stabilizer - 00802357642656

No Description
MEDICAL SPECIALTIES INCORPORATED
264265
In Commercial Distribution

  • 00802357642656 ()


  • Ankle/foot orthosis

Supinator PTT Stabilizer - 00802357642649

No Description
MEDICAL SPECIALTIES INCORPORATED
264264
In Commercial Distribution

  • 00802357642649 ()


  • Ankle/foot orthosis

Supinator PTT Stabilizer - 00802357642625

No Description
MEDICAL SPECIALTIES INCORPORATED
264262
In Commercial Distribution

  • 00802357642625 ()


  • Ankle/foot orthosis

Supinator PTT Stabilizer - 00802357642618

No Description
MEDICAL SPECIALTIES INCORPORATED
264261
In Commercial Distribution

  • 00802357642618 ()


  • Ankle/foot orthosis

Supinator PTT Stabilizer - 00802357642564

No Description
MEDICAL SPECIALTIES INCORPORATED
264256
In Commercial Distribution

  • 00802357642564 ()


  • Ankle/foot orthosis

Supinator PTT Stabilizer - 00802357642557

No Description
MEDICAL SPECIALTIES INCORPORATED
264255
In Commercial Distribution

  • 00802357642557 ()


  • Ankle/foot orthosis

Supinator PTT Stabilizer - 00802357642540

No Description
MEDICAL SPECIALTIES INCORPORATED
264254
In Commercial Distribution

  • 00802357642540 ()


  • Ankle/foot orthosis

Supinator PTT Stabilizer - 00802357642526

No Description
MEDICAL SPECIALTIES INCORPORATED
264252
In Commercial Distribution

  • 00802357642526 ()


  • Ankle/foot orthosis

Supinator PTT Stabilizer - 00802357642519

No Description
MEDICAL SPECIALTIES INCORPORATED
264251
In Commercial Distribution

  • 00802357642519 ()


  • Ankle/foot orthosis
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