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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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GYNECARE VERSAPOINT - 10705031000919

Resectoscopic System, Bridge - Hysteroscopic (Obturator - Visual)
Ethicon Inc.
01735
Not in Commercial Distribution

  • 10705031000919 ()
01735

  • Rigid endoscope obturator

ORTHOSOURCE - D9115574670

Blue Etch 60 ml syringe
ORTHOSOURCE
557-467
In Commercial Distribution

  • D9115574670 ()
  • D911557467601 ()


  • Dental etching solution

ORTHOSOURCE - D9115574660

Green Etch 60 ml syringe
ORTHOSOURCE
557-466
In Commercial Distribution

  • D911557466601 ()
  • D9115574660 ()


  • Dental etching solution

ORTHOSOURCE - D9115574680

Red Etch 60 ml syringe
ORTHOSOURCE
557-468
In Commercial Distribution

  • D911557468601 ()
  • D9115574680 ()


  • Dental etching solution

Shower Seat - 05707581000751

No Description
Ropox A/S
Foldable, with leg
In Commercial Distribution

  • 05707581000751 ()
40-43011-2

  • Shower seat, non-powered

zuvo - 00850041729084

zuvo 16 with eyespeak, speech generating device
Talk To ME Technologies, LLC
16 with eyespeak
In Commercial Distribution

  • 00850041729084 ()


  • Voice synthesizer/digitizer

zuvo - 00850041729077

zuvo 12 with eyespeak, speech generating device
Talk To ME Technologies, LLC
12 with eyespeak
In Commercial Distribution

  • 00850041729077 ()


  • Voice synthesizer/digitizer

Prosomnus IA MicrO2 with Patient Monitoring - 00863039000447

Obstructive Sleep Apnea Device with twin mated posts and Patient Monitoring
PROSOMNUS SLEEP TECHNOLOGIES
MicrO2 with Monitoring
In Commercial Distribution

  • 00863039000447 ()


  • Mandible-repositioning sleep-disordered breathing orthosis

Epredia - 05051663517904

Rotary Microtome - Accessory
SHANDON DIAGNOSTICS LIMITED
Cool-Cut with STD
In Commercial Distribution

  • 05051663517904 ()
771120

  • Rotary microtome IVD

Epredia - 05051663517898

Rotary Microtome - Accessory
SHANDON DIAGNOSTICS LIMITED
Cool-Cut with UCC
In Commercial Distribution

  • 05051663517898 ()
771110

  • Rotary microtome IVD
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