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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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BANDTITE GLASS IONOMER CEMENT KIT
AMERICAN ORTHODONTICS CORPORATION
001-970
In Commercial Distribution

  • 00190746007842 ()
001-970

  • Orthodontic bracket adhesive
Cross-linking agent containing silan agent to improve adhesion
ITENA CLINICAL
SILAN-IT
In Commercial Distribution

  • 03760260223119 ()


  • Dental prosthesis priming agent
No Description
MAXILL, INC.
40533
In Commercial Distribution

  • 00060705405333 ()
  • 90060705405336 ()


  • Dental cavity varnish
No Description
MAXILL, INC.
40532
In Commercial Distribution

  • 00060705405326 ()
  • 90060705405329 ()


  • Dental cavity varnish
No Description
MAXILL, INC.
40531
In Commercial Distribution

  • 00060705405319 ()
  • 90060705405312 ()


  • Dental cavity varnish
No Description
MAXILL, INC.
40530
In Commercial Distribution

  • 00060705405302 ()
  • 90060705405305 ()


  • Dental cavity varnish
105-8101-500 ONYX HD500 KIT ANEURYS
Micro Therapeutics, Inc.
105-8101-500
In Commercial Distribution

  • 00836462005129 ()


  • Neurovascular embolization plug
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
No Description
SEPTODONT, INC
01E0130
In Commercial Distribution

  • 10303620001417 ()

  • Weight: 7.5 Gram


  • Orthodontic bracket adhesive
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
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