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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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Imaging Plate - 60889971251695

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

  • 60889971251695 ()
  • 00889971251693 ()
1251693

  • Digital imaging storage phosphor screen

LANEX Regular Screens - 60889971231291

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

  • 60889971231291 ()
1231299

  • X-ray intensifying screen

CS 7600 Smart Plate - 60889971060167

50PC CS7600 SMART PLATE SIZE 4 V2 BULK
CARESTREAM HEALTH, INC.
CS 7600 Smart Plate
In Commercial Distribution

  • 60889971060167 ()
  • 00889971060165 ()
1060169

  • Digital imaging storage phosphor screen

CS 7600 Smart Plate - 60889971060150

50PC CS7600 SMART PLATE SIZE 3 V2 BULK
CARESTREAM HEALTH, INC.
CS 7600 Smart Plate
In Commercial Distribution

  • 60889971060150 ()
  • 00889971060158 ()
1060151

  • Digital imaging storage phosphor screen

CS 7600 Smart Plate - 60889971060143

50PC CS7600 SMART PLATE SIZE 2 V2 BULK
CARESTREAM HEALTH, INC.
CS 7600 Smart Plate
In Commercial Distribution

  • 60889971060143 ()
  • 00889971060141 ()
1060144

  • Digital imaging storage phosphor screen

CS 7600 Smart Plate - 60889971060136

50PC CS7600 SMART PLATE SIZE 1 V2 BULK
CARESTREAM HEALTH, INC.
CS 7600 Smart Plate
In Commercial Distribution

  • 60889971060136 ()
  • 00889971060134 ()
1060136

  • Digital imaging storage phosphor screen

CS 7600 Smart Plate - 60889971060129

50PC CS7600 SMART PLATE SIZE 0 V2 BULK
CARESTREAM HEALTH, INC.
CS 7600 Smart Plate
In Commercial Distribution

  • 60889971060129 ()
  • 00889971060127 ()
1060128

  • Digital imaging storage phosphor screen

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® 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®, 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
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