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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 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

RVG 6100 - 60192155314162

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 - 60192155313981

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 - 60192155311307

RVG 5200 SIZE 2
CARESTREAM DENTAL LLC
RVG 5200
In Commercial Distribution

  • 60192155311307 ()
5311303

  • Dental digital imaging sensor, intraoral

RVG 5200 - 60192155311291

RVG 5200 SIZE 1
CARESTREAM DENTAL LLC
RVG 5200
In Commercial Distribution

  • 60192155311291 ()
5311295

  • Dental digital imaging sensor, intraoral

ROM Plus® Strip Quality Control - 00814247020468

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 Kit - 00814247020451

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®, Fetal Membranes Rupture Collection Kit - 00814247020444

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®, Fetal Membranes Rupture Test - 00814247020437

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®, Fetal Membranes Rupture Test - 00814247020420

ROM Plus® Complete Test Kit
CLINICAL INNOVATIONS, LLC
ROM-5000
In Commercial Distribution

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


  • Amniotic fluid leak detection device IVD

ROM Plus®, Fetal Membranes Rupture Test - 00814247020406

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

SEPTODONT CIMPAT S 4 - 7.5GM SYR KIT - 10303620001417

No Description
SEPTODONT, INC
01E0130
In Commercial Distribution

  • 10303620001417 ()

  • Weight: 7.5 Gram


  • Orthodontic bracket adhesive

LANEX Regular Screens - 40889971414683

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

  • 60889971414687 ()
  • 40889971414683 ()
1414689

  • X-ray intensifying screen

DIRECTVIEW CR Mammography Cassette with EHR-M Screen - 40889971342863

18X24CM DVIEW CR MAMMO SCR EHR-M2
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with EHR-M Screen
In Commercial Distribution

  • 60889971342867 ()
  • 40889971342863 ()
1342864

  • Digital imaging cassette/storage phosphor screen, mammographic

Imaging Plate - 40889971340074

(2) SZ 2 DENTAL CR I/O IMAG PLATES
CARESTREAM HEALTH, INC.
Imaging Plate
In Commercial Distribution

  • 60889971340078 ()
  • 40889971340074 ()
  • 00889971340076 ()
1340074

  • Digital imaging storage phosphor screen

CS 7400 - 40889971337227

CR SEMI-FIN PLATE PAN V2 15X30CM
CARESTREAM HEALTH, INC.
CS 7400
In Commercial Distribution

  • 60889971337221 ()
  • 40889971337227 ()
1337229

  • Dental computed radiography digital imaging scanner

DIRECTVIEW CR Mammography Cassette with EHR-M Screen - 40889971290386

DIRECTVW CR Mammo Cass EHR-M2 Scrn 18x24
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with EHR-M Screen
Not in Commercial Distribution

  • 60889971290380 ()
  • 40889971290386 ()
1290386

  • Digital imaging cassette/storage phosphor screen, mammographic

DIRECTVIEW CR Cassette with HR Screen - 40889971269672

DIRECTVIEW CR Cassett with HR Scrn 18x24
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with HR Screen
Not in Commercial Distribution

  • 60889971269676 ()
  • 40889971269672 ()
1269679

  • Digital imaging cassette/phosphor plate

LANEX Regular Screens - 40889971207377

LANEX Regular SCR 1PR 8x10in
CARESTREAM HEALTH, INC.
LANEX Regular Screens
In Commercial Distribution

  • 60889971207371 ()
  • 40889971207377 ()
1207372

  • X-ray intensifying screen

Imaging Plate - 40889971098913

CR SEMI-FIN PLATE CEPH 18X24CM
CARESTREAM HEALTH, INC.
Imaging Plate
In Commercial Distribution

  • 60889971098917 ()
  • 40889971098913 ()
1098912

  • Digital imaging storage phosphor screen

Imaging Plate - 40889971067568

Imaging Plate #2 - 4 Pcs
CARESTREAM HEALTH, INC.
Imaging Plate
In Commercial Distribution

  • 60889971067562 ()
  • 40889971067568 ()
  • 00889971067560 ()
1067560

  • Digital imaging storage phosphor screen

Imaging Plate - 40889971067551

Imaging Plate #1 - 4 Pcs
CARESTREAM HEALTH, INC.
Imaging Plate
In Commercial Distribution

  • 60889971067555 ()
  • 40889971067551 ()
  • 00889971067553 ()
1067552

  • Digital imaging storage phosphor screen

Imaging Plate - 40889971067544

Imaging Plate #0 - 4 Pcs
CARESTREAM HEALTH, INC.
Imaging Plate
In Commercial Distribution

  • 60889971067548 ()
  • 40889971067544 ()
  • 00889971067546 ()
1067545

  • Digital imaging storage phosphor screen

CS 7200 - 40889971067513

Hygienic Sheaths #2 - 200 Pcs
CARESTREAM HEALTH, INC.
CS 7200
In Commercial Distribution

  • 60889971067517 ()
  • 40889971067513 ()
  • 00889971067515 ()
1067511

  • Dental computed radiography digital imaging scanner

CS 7200 - 40889971067506

Hygienic Sheaths #1 - 200 Pcs
CARESTREAM HEALTH, INC.
CS 7200
In Commercial Distribution

  • 60889971067500 ()
  • 40889971067506 ()
  • 00889971067508 ()
1067503

  • Dental computed radiography digital imaging scanner

Hygienic Sheaths - 40889971067490

Hygienic Sheaths #0 - 200 Pcs
CARESTREAM HEALTH, INC.
Hygienic Sheaths
In Commercial Distribution

  • 60889971067494 ()
  • 40889971067490 ()
  • 00889971067492 ()
1067495

  • Cable/lead/sensor/probe cover, sterile

CS 7600 Smart Plate - 40889971060019

CS7600 SMART PLATE SIZE 4 V2 - 2 PCS
CARESTREAM HEALTH, INC.
CS 7600 Smart Plate
In Commercial Distribution

  • 60889971060013 ()
  • 40889971060019 ()
  • 00889971060011 ()
1060011

  • Digital imaging storage phosphor screen

CS 7600 Smart Plate - 40889971059990

CS7600 SMART PLATE SIZE 3 V2 - 4 PCS
CARESTREAM HEALTH, INC.
CS 7600 Smart Plate
In Commercial Distribution

  • 60889971059994 ()
  • 40889971059990 ()
  • 00889971059992 ()
1059997

  • Digital imaging storage phosphor screen

CS 7600 Smart Plate - 40889971059983

CS7600 SMART PLATE SIZE 2 V2 - 4 PCS
CARESTREAM HEALTH, INC.
CS 7600 Smart Plate
In Commercial Distribution

  • 60889971059987 ()
  • 40889971059983 ()
  • 00889971059985 ()
1059989

  • Digital imaging storage phosphor screen

CS 7600 Smart Plate - 40889971059969

CS7600 SMART PLATE SIZE 1 V2 - 4 PCS
CARESTREAM HEALTH, INC.
CS 7600 Smart Plate
In Commercial Distribution

  • 60889971059963 ()
  • 40889971059969 ()
  • 00889971059961 ()
1059963

  • Digital imaging storage phosphor screen
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