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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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CHANG Amnio - 00810195240590

CHANG Amnio with Gentamicin and L-Glutamine. 100mL bottle.
IRVINE SCIENTIFIC, LLC
99473-100ML
In Commercial Distribution

  • 00810195240590 ()
99473

  • Cell culture medium IVD

CHANG Medium D with Gentamicin - 00810195240583

CHANG Medium D with Gentamicin for Human Amniotic Fluid Cells. 100mL bottle.
IRVINE SCIENTIFIC, LLC
99404-100ML
In Commercial Distribution

  • 00810195240583 ()
99404

  • Cell culture medium IVD

CHANG Marrow - 00810195240576

Bone Marrow Culture Medium with Gentamicin. 500mL bottle.
IRVINE SCIENTIFIC, LLC
91031-500ML
In Commercial Distribution

  • 00810195240576 ()
91031

  • Cell culture medium IVD

Para 12 Extend - 50844509000612

A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 1 vial of normal level.
STRECK, INC.
218752
In Commercial Distribution

  • 50844509000612 ()

  • Total Volume: 2.5 Milliliter
218752

  • Full blood count IVD, control

Vue RIS - 60889978671366

RIS SOFTWARE < 25K EXAMS / YEAR
CARESTREAM HEALTH, INC.
Vue RIS
In Commercial Distribution

  • 60889978671366 ()
8671364

  • Radiology information system application software

E Blue X-ray Film WB - 60889976046050

25SH 14X36IN E BLUE X-RAY WB (FLAT)
CARESTREAM HEALTH, INC.
E Blue X-ray Film WB
Not in Commercial Distribution

  • 60889976046050 ()
  • 00889976046058 ()
6046056

  • Medical x-ray film, screen

E Green X-ray Film WB - 60889976045978

25SH 14X36IN E GREEN X-RAY WB (FLAT)
CARESTREAM HEALTH, INC.
E Green X-ray Film WB
Not in Commercial Distribution

  • 60889976045978 ()
  • 00889976045976 ()
6045975

  • Medical x-ray film, screen

DIRECTVIEW CR Cassette with PQ Screen - 60889971933980

10SC 35X35CM DIRECTVIEW PQ SCR
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889971933980 ()
  • 00088997193398 ()
1933985

  • Digital imaging cassette/phosphor plate

Full Blue X-ray Film WB - 60889976041383

25SH 14X36IN (FLAT) BLUE X-RAY WB
CARESTREAM HEALTH, INC.
Full Blue X-ray Film WB
Not in Commercial Distribution

  • 60889976041383 ()
  • 00889976041381 ()
6041388

  • Medical x-ray film, screen

Green X-ray Film WB - 60889976041376

25SH 14X36IN (FLAT) GREEN X-RAY WB
CARESTREAM HEALTH, INC.
Green X-ray Film WB
Not in Commercial Distribution

  • 60889976041376 ()
  • 00889976041374 ()
6041370

  • Medical x-ray film, screen
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