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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10SC 10X12 UB REPLACE PHSPHR CR SCN
CARESTREAM HEALTH, INC.
Imaging Plate
In Commercial Distribution

  • 60889971251695 ()
  • 00889971251693 ()
1251693

  • Digital imaging storage phosphor screen
SGL 35X43CM DIRECTVIEW PQ SCR
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889971089410 ()
1089416

  • Digital imaging cassette/phosphor plate
CARESTREAM CR CASS W SCRN 8X10IN
CARESTREAM HEALTH, INC.
CR Cassettes for Vita Systems
In Commercial Distribution

  • 60889971033741 ()
1033745

  • Digital imaging cassette/phosphor plate
CARESTREAM CR CASS W SCRN 10X12IN
CARESTREAM HEALTH, INC.
CR Cassettes for Vita Systems
In Commercial Distribution

  • 60889971033734 ()
1033737

  • Digital imaging cassette/phosphor plate
CARESTREAM CR CASS W SCRN 14X17IN
CARESTREAM HEALTH, INC.
CR Cassettes for Vita Systems
In Commercial Distribution

  • 60889971033727 ()
1033729

  • Digital imaging cassette/phosphor plate
35X35CM CR CASS/PQ/RIGID 100MICRON
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889971031761 ()
1031764

  • Digital imaging cassette/phosphor plate
RVG 6100 - SIZE 0 w/o USB HUB
CARESTREAM DENTAL LLC
RVG 6100
In Commercial Distribution

  • 60192155314162 ()
5314166

  • Dental digital imaging sensor, intraoral
RVG 6200 #1 FOR USE W. RVG CONNECT
CARESTREAM DENTAL LLC
RVG 6200
In Commercial Distribution

  • 60192155313981 ()
5313986

  • Dental digital imaging sensor, intraoral
RVG 5200 SIZE 2
CARESTREAM DENTAL LLC
RVG 5200
In Commercial Distribution

  • 60192155311307 ()
5311303

  • Dental digital imaging sensor, intraoral
RVG 5200 SIZE 1
CARESTREAM DENTAL LLC
RVG 5200
In Commercial Distribution

  • 60192155311291 ()
5311295

  • Dental digital imaging sensor, intraoral
X-OMATIC Regular SCR 1PR 15x30cm hinged
CARESTREAM HEALTH, INC.
X-OMATIC Regular Screens
In Commercial Distribution

  • 60889978387540 ()
8387540

  • X-ray intensifying screen
DIRECTVIEW CR Mammo Cassett HR Scrn18x24
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with HR Screen
In Commercial Distribution

  • 60889978364763 ()
8364762

  • Digital imaging cassette/storage phosphor screen, mammographic
24X30CM DVIEW CR MAMMO SCR EHR-M2
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with EHR-M Screen
In Commercial Distribution

  • 60889978359158 ()
8359150

  • Digital imaging cassette/storage phosphor screen, mammographic
24X30CM DVIEW CR MAMMO SCR EHR-M
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with EHR-M Screen
In Commercial Distribution

  • 60889978346134 ()
8346132

  • Digital imaging cassette/storage phosphor screen, mammographic
PANORAMIC CASSETTE 15X30CM
CARESTREAM HEALTH, INC.
CS 7400
In Commercial Distribution

  • 60889978333882 ()
8333882

  • Dental computed radiography digital imaging scanner
CR IMAGING PLATES PAN 5X12IN
CARESTREAM HEALTH, INC.
Imaging Plate
Not in Commercial Distribution

  • 60889978304899 ()
8304891

  • Digital imaging storage phosphor screen
24x30CM DV CR REPLACMT PLATE/PQ SCR
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889978294459 ()
8294456

  • Digital imaging cassette/phosphor plate
Point-of-Care CR Cass W SCRN TYP A 35x43
CARESTREAM HEALTH, INC.
Point-of-Care CR Cassette with Screen Type A
In Commercial Distribution

  • 60889978284528 ()
8284523

  • Digital imaging cassette/phosphor plate
CARESTREAM CR Cassette 28x35 / 11x14
CARESTREAM HEALTH, INC.
CR Cassettes for Vita Systems
In Commercial Distribution

  • 60889978216369 ()
8216368

  • Digital imaging cassette/phosphor plate
24X30 CR MAMMO CASS W/SNP-M1 SCREEN
CARESTREAM HEALTH, INC.
CARESTREAM CR Mammography Cassette with SNP-M1 Screen
In Commercial Distribution

  • 60889978215201 ()
8215204

  • Digital imaging cassette/storage phosphor screen, mammographic
X-OMATIC Regular SCR 1PR 4.88x14.75in H
CARESTREAM HEALTH, INC.
X-OMATIC Regular Screens
In Commercial Distribution

  • 60889978150328 ()
8150328

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

  • 60889978114658 ()
8114654

  • X-ray intensifying screen
15x30CM DV CR REPLACMT PLATE/PQ SCR
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889978104147 ()
8104143

  • Digital imaging cassette/phosphor plate
CR IMAGING PLATES CEPH 18X24CM
CARESTREAM HEALTH, INC.
Imaging Plate
In Commercial Distribution

  • 60889978025428 ()
8025421

  • Digital imaging storage phosphor screen
RVG 6100 #2 Operatory Kit
CARESTREAM HEALTH, INC.
RVG 6100
In Commercial Distribution

  • 60889978024391 ()
8024390

  • Dental digital imaging sensor, intraoral
RVG 6100 #1 Operatory Kit
CARESTREAM HEALTH, INC.
RVG 6200
In Commercial Distribution

  • 60889978024384 ()
8024382

  • Dental digital imaging sensor, intraoral
RVG 6100 #0 Operatory Kit
CARESTREAM HEALTH, INC.
RVG 6100
In Commercial Distribution

  • 60889978024377 ()
8024374

  • Dental digital imaging sensor, intraoral
6100 Size 2 Upgrade
CARESTREAM HEALTH, INC.
RVG 6100
Not in Commercial Distribution

  • 60889978024360 ()
8024366

  • Dental digital imaging sensor, intraoral
6100 Size 1 Upgrade
CARESTREAM HEALTH, INC.
RVG 6100
Not in Commercial Distribution

  • 60889978024353 ()
8024358

  • Dental digital imaging sensor, intraoral
6100 SZ 0 Upgrade
CARESTREAM HEALTH, INC.
RVG 6100
Not in Commercial Distribution

  • 60889978001491 ()
8001497

  • Dental digital imaging sensor, intraoral
RVG 6100 - SIZE 0 w/o USB HUB
CARESTREAM HEALTH, INC.
RVG 6100
In Commercial Distribution

  • 60889975314167 ()
5314166

  • Dental digital imaging sensor, intraoral
RVG 6100 - SIZE 2 w/o USB HUB
CARESTREAM HEALTH, INC.
RVG 6100
In Commercial Distribution

  • 60889975314129 ()
5314125

  • Dental digital imaging sensor, intraoral
RVG 5100 - SIZE 2 w/o USB HUB
CARESTREAM HEALTH, INC.
RVG 5100
In Commercial Distribution

  • 60889975314105 ()
5314109

  • Dental digital imaging sensor, intraoral
RVG 5100 - SIZE 1 w/o USB HUB
CARESTREAM HEALTH, INC.
RVG 5100
In Commercial Distribution

  • 60889975314099 ()
5314091

  • Dental digital imaging sensor, intraoral
RVG 5200 SIZE 2
CARESTREAM HEALTH, INC.
RVG 5200
In Commercial Distribution

  • 60889975311302 ()
5311303

  • Dental digital imaging sensor, intraoral
EV SCR, 20PR 15x30cm-Panoramic
CARESTREAM HEALTH, INC.
EV Screens
In Commercial Distribution

  • 60889971015556 ()
1015551

  • X-ray intensifying screen
Extraoral Cass w/ LANEX REG SCR 18x24cm
CARESTREAM HEALTH, INC.
Extraoral Cassette with LANEX Regular Screens
Not in Commercial Distribution

  • 60889971002815 ()
1002815

  • X-ray film cassette, automatic film changing
  • X-ray intensifying screen
Extraoral Cass w/ LANEX REG SCR 8x10in
CARESTREAM HEALTH, INC.
Extraoral Cassette with LANEX Regular Screens
In Commercial Distribution

  • 60889971002808 ()
1002807

  • X-ray intensifying screen
  • X-ray film cassette, automatic film changing
Extraoral Cass w/ EV SCR 8x10in
CARESTREAM HEALTH, INC.
Extraoral Cassette with EV Screens
In Commercial Distribution

  • 60889971002785 ()
1002781

  • X-ray film cassette, automatic film changing
  • X-ray intensifying screen
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 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 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
CS 7600 SLOT PANEL SIZE 4
CARESTREAM HEALTH, INC.
CS 7600 SLOT PANEL
In Commercial Distribution

  • 60889971023711 ()
1023712

  • Dental computed radiography digital imaging scanner
CS 7600 SLOT PANEL SIZE 1-3
CARESTREAM HEALTH, INC.
CS 7600 SLOT PANEL
In Commercial Distribution

  • 60889971023704 ()
1023704

  • Dental computed radiography digital imaging scanner
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
ROM Plus®, Quality Control for Fetal Membranes Rupture Test
CLINICAL INNOVATIONS, LLC
ROM-QC
In Commercial Distribution

  • 20814247020455 ()
  • 10814247020458 ()
  • 00814247020451 ()


  • Amniotic fluid leak detection device IVD
ROM Plus® Complete Kit Fetal Membranes Rupture Test
CLINICAL INNOVATIONS, LLC
ROM-6000
In Commercial Distribution

  • 20814247020448 ()
  • 10814247020441 ()
  • 00814247020444 ()


  • Amniotic fluid leak detection device IVD
ROM Plus® Complete Kit Fetal Membranes Rupture Test
CLINICAL INNOVATIONS, LLC
ROM-5025
In Commercial Distribution

  • 10814247020434 ()
  • 00814247020437 ()


  • Amniotic fluid leak detection device IVD
ROM Plus® Complete Test Kit
CLINICAL INNOVATIONS, LLC
ROM-5000
In Commercial Distribution

  • 20814247020424 ()
  • 10814247020427 ()
  • 00814247020420 ()


  • Amniotic fluid leak detection device IVD
ROM Plus® Easy Strip Complete Kit Fetal Membranes Rupture Test
CLINICAL INNOVATIONS, LLC
ROM-1025
In Commercial Distribution

  • 00814247020406 ()
  • 10814247020403 ()
  • 20814247020400 ()


  • Amniotic fluid leak detection device IVD
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