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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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PureWick Female External Catheter, Not Made with Natural Rubber Latex, Kit
C. R. Bard, Inc.
PWF030K
In Commercial Distribution

  • 20801741183618 ()
  • 10801741183611 ()
  • 00801741183614 ()
PWF030K

  • Female wearable urinal, single-use
Self-sealing sterilization pouches with internal and external multi-variable (parameter) chemical indicator
Scican Ltd
SCI-SCP
Not in Commercial Distribution

  • 27540196001650 ()
  • 17540196001653 ()
  • 07540196001656 ()
SCI-SCP

  • Sterilization packaging, single-use
IntelliVue TcG10 Gas Modul for external transcutaneous O2 and CO2 measurement
Philips Medizin Systeme Böblingen GmbH
IntelliVue TcG10
Not in Commercial Distribution

  • 00884838020764 ()
865298

  • Transcutaneous blood gas monitoring system
eCoin Patient Kit
Valencia Technologies Corporation
1011-1901
In Commercial Distribution

  • 00860007896965 ()


  • Tibial nerve implantable incontinence-control electrical stimulation system
Revi™ System Physician Kit is intended to provide physicians necessary device system components to support therapy.
BLUEWIND MEDICAL LTD
KA-9000-0002_US_CM
In Commercial Distribution

  • 07290017912332 ()


  • Tibial nerve implantable incontinence-control electrical stimulation system
Revi System Patient Kit intended for patient use containing device components to support therapy.
BLUEWIND MEDICAL LTD
KA-9000-0001_US_CM
In Commercial Distribution

  • 07290017912226 ()


  • Tibial nerve implantable incontinence-control electrical stimulation system
The Revi Clinician Programmer is an application that is the Revi system's interface.
BLUEWIND MEDICAL LTD
DV-9500-0001_US_CM
In Commercial Distribution

  • 07290017912035 ()


  • Tibial nerve implantable incontinence-control electrical stimulation system
The Revi Wearable Device wirelessly powers the Revi Implant and enables control of stimulation parameters.
BLUEWIND MEDICAL LTD
MA-1004-0500
In Commercial Distribution

  • 07290017912028 ()


  • Tibial nerve implantable incontinence-control electrical stimulation system
External Baterry Charger of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Compliance Monitoring System (Model: BcAc-DCK-1000)
BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SA
BcAc-DCK-1000
In Commercial Distribution

  • 07908398200084 ()

  • Length: 75.6 Millimeter
  • Width: 51.5 Millimeter
  • Height: 15.7 Millimeter


  • Intracranial pressure monitor
External Penile Rigidity Device that contains kit bag, battery vacuum pump, tension systems, cylinder, lubricant, comfort inserts, loading cone, 9 volt battery.
AUGUSTA MEDICAL SYSTEMS, L.L.C.
External Penile Rigidity Device
In Commercial Distribution

  • 00852598007196 ()


  • Penile vacuum device
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