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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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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
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