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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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EV Screens - 60889971791177

EV SCR 1PR 4.88x14.75in hinged
CARESTREAM HEALTH, INC.
EV Screens
In Commercial Distribution

  • 60889971791177 ()
1791177

  • X-ray intensifying screen

LANEX Regular Screens - 60889971717740

LANEX Regular SCR 20PR 8x10in NF
CARESTREAM HEALTH, INC.
LANEX Regular Screens
In Commercial Distribution

  • 60889971717740 ()
  • 00889971717748 ()
1717743

  • X-ray intensifying screen

DIRECTVIEW CR Mammography Cassette with HR Screen - 60889971717443

10SC 18X24CM ESCN HR PHOSPHOR SCR
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with HR Screen
In Commercial Distribution

  • 60889971717443 ()
  • 00889971717441 ()
1717446

  • Digital imaging cassette/storage phosphor screen, mammographic

CR Cassettes for Vita Systems - 60889971696830

CARESTREAM CR Cassette 35x83/14x33
CARESTREAM HEALTH, INC.
CR Cassettes for Vita Systems
In Commercial Distribution

  • 60889971696830 ()
1696830

  • Digital imaging cassette/phosphor plate

DIRECTVIEW CR Mammography Cassette with HR Screen - 60889971650511

DIRECTVIEW CR Cassett with HR Scrn 24x30
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with HR Screen
Not in Commercial Distribution

  • 60889971650511 ()
1650514

  • Digital imaging cassette/storage phosphor screen, mammographic

DIRECTVIEW CR Cassette with PQ Screen - 60889971640987

35x35CM DV CR REPLACMT PLATE/PQ SCR
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889971640987 ()
1640986

  • Digital imaging cassette/phosphor plate

CR Cassettes for Vita Systems - 60889971627582

CARESTREAM CR Cassette 15x30 cm
CARESTREAM HEALTH, INC.
CR Cassettes for Vita Systems
In Commercial Distribution

  • 60889971627582 ()
1627587

  • Digital imaging cassette/phosphor plate

X-OMATIC Regular Screens - 60889971604019

X-OMATIC Regular SCR 1PR 15x30cm NF
CARESTREAM HEALTH, INC.
X-OMATIC Regular Screens
In Commercial Distribution

  • 60889971604019 ()
1604016

  • X-ray intensifying screen

DIRECTVIEW CR Cassette with PQ Screen - 60889971603241

35X43CM CR CASS/PQ/RIGID 100MICRON
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889971603241 ()
1603240

  • Digital imaging cassette/phosphor plate

DIRECTVIEW CR Cassette with PQ Screen - 60889971600004

10SC 24X30CM DIRECTVIEW PQ SCR
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889971600004 ()
  • 00889971600002 ()
1600006

  • Digital imaging cassette/phosphor plate
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