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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 - 10705031000926

Resectoscopic System, Working Element, Passive
Ethicon Inc.
01931
Not in Commercial Distribution

  • 10705031000926 ()
01931

  • Electrosurgical handpiece/electrode holder, reusable

GYNECARE VERSAPOINT - 10705031000919

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

  • 10705031000919 ()
01735

  • Rigid endoscope obturator

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

FaceLake - 00851908007062

The 50EW is a rechargeable pulse oximeter that is designed to accurately measure oxygen saturation (SpO2) and pulse rate through your finger.
LORTE TECHNOLOGIES, INC
CMS-50EW with Bluetooth
In Commercial Distribution

  • 00851908007062 ()


  • Pulse oximeter

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

ESTREMO - 08052990979608

No Description
CITIEFFE SRL
Obturator with handle
In Commercial Distribution

  • 08052990979608 ()
DT030090

  • Surgical drill guide obturator

ESTREMO - 08052990976300

No Description
CITIEFFE SRL
Cannula with handle
In Commercial Distribution

  • 08052990976300 ()
DT030022

  • Surgical drill guide, reusable

Headrest - 07640132986549

No Description
Haag-Streit AG
With Lower Part
In Commercial Distribution

  • 07640132986549 ()
1021554

  • Ophthalmic examination slit lamp
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