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

  • 07640132986549 ()
1021554

  • Ophthalmic examination slit lamp
zuvo 16 with eyespeak, speech generating device
Talk To ME Technologies, LLC
16 with eyespeak
In Commercial Distribution

  • 00850041729084 ()


  • Voice synthesizer/digitizer
zuvo 12 with eyespeak, speech generating device
Talk To ME Technologies, LLC
12 with eyespeak
In Commercial Distribution

  • 00850041729077 ()


  • Voice synthesizer/digitizer
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
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
No Description
LUMENIS LTD.
With Vacuum Tubing
In Commercial Distribution

  • 07290109141824 ()


  • General/multiple surgical solid-state/carbon dioxide laser system
MRI multi-channel optical communication system
OPTOACOUSTICS LTD
IMROC-IR with OptoACTIVE
In Commercial Distribution

  • 07290019141006 ()


  • Patient audiovisual communication/entertainment system
No Description
CITIEFFE SRL
Obturator with handle
In Commercial Distribution

  • 08052990979608 ()
DT030090

  • Surgical drill guide obturator
No Description
CITIEFFE SRL
Cannula with handle
In Commercial Distribution

  • 08052990976300 ()
DT030022

  • Surgical drill guide, reusable
No Description
CITIEFFE SRL
Cannula with handle
In Commercial Distribution

  • 08032909620548 ()
EBA-0155

  • Surgical drill guide, reusable
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