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

  • 60889971604019 ()
1604016

  • X-ray intensifying screen
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
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
20PR 15X30CM XMT R HG CP F/PANRMC
CARESTREAM HEALTH, INC.
X-OMATIC Regular Screens
Not in Commercial Distribution

  • 60889971584465 ()
1584465

  • X-ray intensifying screen
EV SCR 1PR 5x12in NF
CARESTREAM HEALTH, INC.
EV Screens
In Commercial Distribution

  • 60889971539014 ()
1539014

  • X-ray intensifying screen
X-OMATIC Regular SCR, 1PR 8x10in
CARESTREAM HEALTH, INC.
X-OMATIC Regular Screens
In Commercial Distribution

  • 60889971536051 ()
1536051

  • X-ray intensifying screen
20PR 15X30CM LX M C2 WOFM F/GENDEX
CARESTREAM HEALTH, INC.
LANEX Medium Screens
Not in Commercial Distribution

  • 60889971529015 ()
1529015

  • X-ray intensifying screen
EV SCR 1PR 15x30cm hinged
CARESTREAM HEALTH, INC.
EV Screens
In Commercial Distribution

  • 60889971525673 ()
1525674

  • X-ray intensifying screen
Flexible Phosphor Screen GP-2 15x30 cm
CARESTREAM HEALTH, INC.
Flexible Phosphor Screen GP-2
In Commercial Distribution

  • 60889971522436 ()
1522432

  • Digital imaging storage phosphor screen
EV SCR 1PR 8X10IN NF
CARESTREAM HEALTH, INC.
EV Screens
In Commercial Distribution

  • 60889971485397 ()
1485390

  • X-ray intensifying screen
10SC 15X30CM DIRECTVIEW PQ SCR
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889971433701 ()
  • 00889971433709 ()
1433705

  • Digital imaging cassette/phosphor plate
LANEX Regular SCR 1PR 15x30cm hinged
CARESTREAM HEALTH, INC.
LANEX Regular Screens
In Commercial Distribution

  • 60889971414601 ()
1414606

  • X-ray intensifying screen
LANEX Regular SCR 1PR 4.88x14.75in H
CARESTREAM HEALTH, INC.
LANEX Regular Screens
In Commercial Distribution

  • 60889971414540 ()
1414549

  • X-ray intensifying screen
Point-of-Care CR Cass W SCRN TYP A 35x35
CARESTREAM HEALTH, INC.
Point-of-Care CR Cassette with Screen Type A
In Commercial Distribution

  • 60889971395504 ()
1395508

  • Digital imaging cassette/phosphor plate
LANEX Medium SCR 1PR 4.88x14.75in H
CARESTREAM HEALTH, INC.
LANEX Medium Screens
In Commercial Distribution

  • 60889971388124 ()
1388123

  • X-ray intensifying screen
LANEX Medium SCR 1PR 15x30cm hinged
CARESTREAM HEALTH, INC.
LANEX Medium Screens
In Commercial Distribution

  • 60889971367433 ()
1367432

  • X-ray intensifying screen
LANEX Medium SCR 1PR 15x30cm NF
CARESTREAM HEALTH, INC.
LANEX Medium Screens
In Commercial Distribution

  • 60889971292674 ()
1292671

  • X-ray intensifying screen
CARESTREAM CR Cassette 24x30 cm
CARESTREAM HEALTH, INC.
CR Cassettes for Vita Systems
In Commercial Distribution

  • 60889971282682 ()
1282680

  • Digital imaging cassette/phosphor plate
10SC 10X12 UB REPLACE PHSPHR CR SCN
CARESTREAM HEALTH, INC.
Imaging Plate
In Commercial Distribution

  • 60889971251695 ()
  • 00889971251693 ()
1251693

  • Digital imaging storage phosphor screen
EV SCR 1PR 8x10in NF
CARESTREAM HEALTH, INC.
EV Screens
In Commercial Distribution

  • 60889978997329 ()
8997322

  • X-ray intensifying screen
CARESTREAM CR Cassette 25x30/10x12
CARESTREAM HEALTH, INC.
CR Cassettes for Vita Systems
In Commercial Distribution

  • 60889978964390 ()
8964397

  • Digital imaging cassette/phosphor plate
SGL 35X35CM DIRECTVIEW PQ SCR
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889978933884 ()
8933889

  • Digital imaging cassette/phosphor plate
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
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 SCR 20PR 4.88x14.75in H-G
CARESTREAM HEALTH, INC.
LANEX Regular Screens
In Commercial Distribution

  • 60889978802098 ()
  • 00889978802096 ()
8802092

  • X-ray intensifying screen
EV SCR 1PR 15x30cm NF
CARESTREAM HEALTH, INC.
EV Screens
In Commercial Distribution

  • 60889978793457 ()
8793457

  • X-ray intensifying screen
CR IMAGING PLATE PAN V2 5X12IN
CARESTREAM HEALTH, INC.
Imaging Plate
In Commercial Distribution

  • 60889978770717 ()
8770711

  • Digital imaging storage phosphor screen
35X35CM CR CASSETTE GP PLUS
CARESTREAM HEALTH, INC.
CR Cassettes for Vita Systems
In Commercial Distribution

  • 60889978719662 ()
8719668

  • Digital imaging cassette/phosphor plate
10SC 35X43CM DIRECTVIEW PQ SCR
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889978619108 ()
  • 00889978619106 ()
8619108

  • Digital imaging cassette/phosphor plate
24X30CM DV REPLCMT PLATE/EHR-M2 SCR
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with EHR-M Screen
In Commercial Distribution

  • 60889978611614 ()
8611618

  • Digital imaging cassette/storage phosphor screen, mammographic
LANEX Regular SCR 20PR 15x30cm H-Panoram
CARESTREAM HEALTH, INC.
LANEX Regular Screens
In Commercial Distribution

  • 60889978580842 ()
  • 00889978580840 ()
8580847

  • X-ray intensifying screen
105-8101-500 ONYX HD500 KIT ANEURYS
Micro Therapeutics, Inc.
105-8101-500
In Commercial Distribution

  • 00836462005129 ()


  • Neurovascular embolization plug
No Description
MAXILL, INC.
40533
In Commercial Distribution

  • 00060705405333 ()
  • 90060705405336 ()


  • Dental cavity varnish
No Description
MAXILL, INC.
40532
In Commercial Distribution

  • 00060705405326 ()
  • 90060705405329 ()


  • Dental cavity varnish
No Description
MAXILL, INC.
40531
In Commercial Distribution

  • 00060705405319 ()
  • 90060705405312 ()


  • Dental cavity varnish
No Description
MAXILL, INC.
40530
In Commercial Distribution

  • 00060705405302 ()
  • 90060705405305 ()


  • Dental cavity varnish
ROM Plus®, Easy Strip Quality Control for Fetal Membranes Rupture Test
CLINICAL INNOVATIONS, LLC
ROM-QCS
In Commercial Distribution

  • 20814247020462 ()
  • 10814247020465 ()
  • 00814247020468 ()


  • Amniotic fluid leak detection device IVD
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