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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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Extraoral Cassette with LANEX Regular Screens - 60889971002778

Extraoral Cass w/ LANEX REG SCR 15x30cm
CARESTREAM HEALTH, INC.
Extraoral Cassette with LANEX Regular Screens
In Commercial Distribution

  • 60889971002778 ()
1002773

  • X-ray intensifying screen
  • X-ray film cassette, automatic film changing

Extraoral Cassette with LANEX Medium Screens - 60889971002747

Extraoral Cass w/ LANEX MED SCR 15x30cm
CARESTREAM HEALTH, INC.
Extraoral Cassette with LANEX Medium Screens
In Commercial Distribution

  • 60889971002747 ()
1002740

  • X-ray intensifying screen
  • X-ray film cassette, automatic film changing

Extraoral Cassette with EV Screens - 60889971002730

Extraoral Cass w/ EV SCR 15x30cm
CARESTREAM HEALTH, INC.
Extraoral Cassette with EV Screens
In Commercial Distribution

  • 60889971002730 ()
1002732

  • X-ray intensifying screen
  • X-ray film cassette, automatic film changing

DISPETTE® - 07612964013304

DISPETTE 2 SALINE
Guest Scientific AG
FH1600
Not in Commercial Distribution

  • 07612964013311 ()
  • 07612964013304 ()
  • 07612964013342 ()
FH1600

  • Erythrocyte sedimentation rate (ESR) IVD, kit

DISPETTE® - 07612964000762

DISPETTE 2 CITRATE
Guest Scientific AG
FH1650
Not in Commercial Distribution

  • 07612964000809 ()
  • 07612964000762 ()
  • 07612964000786 ()
FH1650

  • Erythrocyte sedimentation rate (ESR) IVD, kit

CR Cassettes for Vita Systems - 60889978964390

CARESTREAM CR Cassette 25x30/10x12
CARESTREAM HEALTH, INC.
CR Cassettes for Vita Systems
In Commercial Distribution

  • 60889978964390 ()
8964397

  • Digital imaging cassette/phosphor plate

DIRECTVIEW CR Cassette with PQ Screen - 60889978933884

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

  • 60889978933884 ()
8933889

  • Digital imaging cassette/phosphor plate

DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen - 60889978869848

24X30CM CR MAMMO SCR EHR-M3
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen
In Commercial Distribution

  • 60889978869848 ()
8869844

  • Digital imaging cassette/storage phosphor screen, mammographic

DIRECTVIEW CR Cassette with PQ Screen - 60889978824601

35x43CM DV CR REPLACMT PLATE/PQ SCR
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889978824601 ()
8824609

  • Digital imaging cassette/phosphor plate

LANEX Regular Screens - 60889978802098

LANEX Regular SCR 20PR 4.88x14.75in H-G
CARESTREAM HEALTH, INC.
LANEX Regular Screens
In Commercial Distribution

  • 60889978802098 ()
  • 00889978802096 ()
8802092

  • X-ray intensifying screen
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