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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

CS 7600 SLOT PANEL - 60889971023704

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

EV Screens - 60889971015556

EV SCR, 20PR 15x30cm-Panoramic
CARESTREAM HEALTH, INC.
EV Screens
In Commercial Distribution

  • 60889971015556 ()
1015551

  • X-ray intensifying screen

DISPETTE® - 07612964013304

DISPETTE 2 SALINE
Guest Scientific AG
FH1600
Not in Commercial Distribution

  • 07612964013311 ()
  • 07612964013304 ()
  • 07612964013342 ()
FH1600

  • Erythrocyte sedimentation rate (ESR) IVD, kit

DISPETTE® - 07612964000762

DISPETTE 2 CITRATE
Guest Scientific AG
FH1650
Not in Commercial Distribution

  • 07612964000809 ()
  • 07612964000762 ()
  • 07612964000786 ()
FH1650

  • Erythrocyte sedimentation rate (ESR) IVD, kit

EV Screens - 60889978997329

EV SCR 1PR 8x10in NF
CARESTREAM HEALTH, INC.
EV Screens
In Commercial Distribution

  • 60889978997329 ()
8997322

  • X-ray intensifying screen

CR Cassettes for Vita Systems - 60889978964390

CARESTREAM CR Cassette 25x30/10x12
CARESTREAM HEALTH, INC.
CR Cassettes for Vita Systems
In Commercial Distribution

  • 60889978964390 ()
8964397

  • Digital imaging cassette/phosphor plate
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