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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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DuraFinish™ - 00810000525195

All-Cure DuraFinish™ Composite Glaze
PARKELL, INC.
S296
In Commercial Distribution

  • 00810000525195 ()
S296

  • Dental unfilled resin sealant/coating

DuraFinish™ - 00810000525188

DuraFinish™ Composite Glaze
PARKELL, INC.
S295
Not in Commercial Distribution

  • 00810000525188 ()
S295

  • Dental unfilled resin sealant/coating

CS 3500 3D Scanner Small Tip - 60889976567883

CS3500 SMALL TIP (5 PIECES)
CARESTREAM HEALTH, INC.
CS 3500 3D Scanner Small Tip
In Commercial Distribution

  • 60889976567883 ()
  • 00889976567881 ()
6567887

  • Dental milling system, CAD/CAM, chairside

CS 3500 3D Scanner Collar - 60889976567876

CS3500 COLLAR PACKING (10 PIECES)
CARESTREAM HEALTH, INC.
CS 3500 3D Scanner Collar
In Commercial Distribution

  • 60889976567876 ()
  • 00889976567874 ()
6567879

  • Dental milling system, CAD/CAM, chairside

LANEX Medium Screens - 60889971997654

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

  • 60889971997654 ()
  • 00889971997652 ()
1997659

  • X-ray intensifying screen

CARESTREAM CR Mammography Cassette with SNP-M1 Screen - 60889971978608

CARESTREAM CR Cassette 35x43 / 14x17
CARESTREAM HEALTH, INC.
CARESTREAM CR Mammography Cassette with SNP-M1 Screen
In Commercial Distribution

  • 60889971978608 ()
1978600

  • Digital imaging cassette/storage phosphor screen, mammographic

Point-of-Care CR Cassette with Screen Type A - 60889971880758

Point-of-Care CR Cass W SCRN TYP A 25x30
CARESTREAM HEALTH, INC.
Point-of-Care CR Cassette with Screen Type A
In Commercial Distribution

  • 60889971880758 ()
1880756

  • Digital imaging cassette/phosphor plate

DIRECTVIEW CR Cassette with PQ Screen - 60889971831989

SGL 18X24CM DIRECTVIEW PQ SCR
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889971831989 ()
1831981

  • Digital imaging cassette/phosphor plate

DIRECTVIEW CR Cassette with PQ Screen - 60889971827296

18x24CM DV CR REPLACMT PLATE/PQ SCR
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889971827296 ()
1827294

  • Digital imaging cassette/phosphor plate

X-OMATIC Regular Screens - 60889971820884

X-OMATIC Regular SCR, 1PR 5x12in NF
CARESTREAM HEALTH, INC.
X-OMATIC Regular Screens
In Commercial Distribution

  • 60889971820884 ()
1820885

  • X-ray intensifying screen
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