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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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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

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

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 LAS - 00195226000535

ACL TOP 770 LAS
INSTRUMENTATION LABORATORY COMPANY
00000280037
In Commercial Distribution

  • 00195226000535 ()
00000280037

  • Coagulation analyser IVD, laboratory

ACL TOP 770 - 00195226000528

ACL TOP 770
INSTRUMENTATION LABORATORY COMPANY
00000280057
In Commercial Distribution

  • 00195226000528 ()
00000280057

  • 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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