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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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The INVOcell Retention Device is a single-use, medical grade silicone device that includes holes to allow for natural drainage of vaginal fluids. The retention device is placed into the vaginal cavity with the INVOcell Culture Device to ensure that the INVOcell Culture Device is retained in the vaginal cavity for the incubation period.
INVO BIOSCIENCE, INC.
P-011
In Commercial Distribution

  • 00862190000358 ()


  • Assisted reproduction procedure dish
The INVOcell Retention Device is a single-use, modified diaphragm that includes holes to allow for natural drainage of vaginal fluids. The retention device is placed into the vaginal cavity with the INVOcell Culture Device to ensure that the INVOcell Culture Device is retained in the vaginal cavity for 72 hours. The INVOcell Retention Device is a commercially-available diaphragm made of medical grade silicone.
INVO BIOSCIENCE, INC.
P-017
Not in Commercial Distribution

  • 00862190000341 ()


  • Assisted reproduction procedure dish
The INVOcell Retention Device is a single-use, modified diaphragm that includes holes to allow for natural drainage of vaginal fluids. The retention device is placed into the vaginal cavity with the INVOcell Culture Device to ensure that the INVOcell Culture Device is retained in the vaginal cavity for 72 hours. The INVOcell Retention Device is a commercially-available diaphragm made of medical grade silicone.
INVO BIOSCIENCE, INC.
P-010
Not in Commercial Distribution

  • 00862190000310 ()


  • Assisted reproduction procedure dish
The Rosetta-Lt Data Translator receives and communicates information from monitor/defibrillators over radio/phone communications systems.
General Devices
Rosetta-Lt Data Translator
Not in Commercial Distribution

  • 00862186000386 ()
040-184-7100

  • Medical networking interface unit
The CAREpoint Workstation (Version 1 and 2) communication console is a standard radio/telephony communications console used for vice and data communications. Personal Computer (PC) based, it contains various means to interface to and control communications elements (i.e. 2 way radio, landline, wireless telephone) as which are commonly used for commercial and public safety (i.e. police, fire, EMS) communication purposes.
General Devices
CAREpoint Workstation
Not in Commercial Distribution

  • 00862186000379 ()
040-183-4000

  • Medical networking interface unit
Earscan 3 Automatic Threshold Audiometer.
MICRO AUDIOMETRICS CORPORATION
ES3
In Commercial Distribution

  • 00862185000325 ()
05.001

  • Tone audiometer, automated
Earscan 3 Screening Audiometer.
MICRO AUDIOMETRICS CORPORATION
ES3S
In Commercial Distribution

  • 00862185000318 ()
04.001

  • Tone audiometer, manual
Earscan 3 Manual Audiometer.
MICRO AUDIOMETRICS CORPORATION
ES3M
In Commercial Distribution

  • 00862185000301 ()
06.001

  • Tone audiometer, manual
Torq ZDrive MR, Ram Scientific
MEDTOX DIAGNOSTICS, INC.
ZZP-MR-RS Rev 0
In Commercial Distribution

  • 00862105000374 ()


  • General-purpose centrifuge IVD
Torq MiniDrive2
MEDTOX DIAGNOSTICS, INC.
ZZP-MD2-1 Rev 0
In Commercial Distribution

  • 00862105000343 ()


  • General-purpose centrifuge IVD
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