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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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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

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

Shower Seat - 05707581000751

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

  • 05707581000751 ()
40-43011-2

  • Shower seat, non-powered

CONTACT PLATE DELTA 20T - 04053755181315

No Description
Heine Optotechnik GmbH & Co. KG
STANDARD WITH SCALE
In Commercial Distribution

  • 04053755181315 ()
K-000.34.216

  • Dermatoscope, optical

CONTACT PLATE MINI3000 - 04053755124039

No Description
Heine Optotechnik GmbH & Co. KG
STANDARD WITH SCALE
In Commercial Distribution

  • 04053755124039 ()
D-000.78.117

  • Dermatoscope, optical

Colonic Irrigation Kit - B482Z170

Colon Hydrotherapy Disposable Single-Use Kit, consisting of a large size Bulb Style Speculum with limiter and Obturator, a water inflow tube, a collapsible waste hose and a 2.5 g sachet of lubricant.
TRANSCENDENCIAS COMERCIALES SL
Hydrokit with limiter
In Commercial Distribution

  • B482Z171 ()
  • B482Z170 ()
Z-17

  • Colonic lavage kit, non-surgical

Ambler Surgical - 00190660127824

Probe with eye, 9'', malleable, sterling silver
AMBLER SURGICAL CORP.
Probe with eye
In Commercial Distribution

  • 00190660127824 ()
44-641

  • Fistula probe

Ambler Surgical - 00190660127817

Probe with eye, 8'', malleable, sterling silver
AMBLER SURGICAL CORP.
Probe with eye
In Commercial Distribution

  • 00190660127817 ()
44-640

  • Fistula probe

Ambler Surgical - 00190660127800

Probe with eye, 8'', malleable, stainless steel
AMBLER SURGICAL CORP.
Probe with eye
In Commercial Distribution

  • 00190660127800 ()
44-630

  • Fistula probe
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