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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® 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
LANEX Regular SCR 1PR 13x18cm
CARESTREAM HEALTH, INC.
LANEX Regular Screens
In Commercial Distribution

  • 60889971976208 ()
  • 40889971976204 ()
1976208

  • X-ray intensifying screen
Automatrix Snippers+ Catch Tray is a part of the Automatrix Snippers+ to prevent clipped loop pieces rom the oral cavity.
Dentsply De Trey GmbH
62422605
In Commercial Distribution

  • D010624226050 ()
  • D010624226051 ()

  • Length: 1.9 Centimeter
62422605

  • Orthodontic pliers
Mixing Tip/ Intraoral Tip is the mixing and application device to be applied with AH Plus Jet and is available seperately
Dentsply De Trey GmbH
60620116
In Commercial Distribution

  • D01060620110 ()
  • D01060620111 ()

  • Length: 5.2 Centimeter
60620116

  • Endodontic filling/sealing material
SmartLite Focus Charging Base is a part of the SmartLite Focus Curing Light and is available separately.
Dentsply De Trey GmbH
64450070
In Commercial Distribution

  • D010644500701 ()

  • Outer Diameter: 6.5 Centimeter
64450070

  • Dental/surgical polymerization lamp
Gingival Retraction Solution
DEN-MAT HOLDINGS, LLC
641960
In Commercial Distribution

  • 00359883005672 ()

  • Total Volume: 60 Milliliter
641960

  • Gingival retraction solution
Precision System with Extension Tube and HV Bone Cement
STRYKER CORPORATION
0507586000
In Commercial Distribution

  • 37613327357852 ()
  • 07613327357851 ()

  • Angle: 90.0 degree
0507-586-000

  • Orthopaedic cement, non-antimicrobial
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