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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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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
Hermetic™ Plus External CSF Drainage System with Needleless Injection Sites
Integra Lifesciences Corporation
INS8302
In Commercial Distribution


  • 700ml drainage bag, 75ml burette chamber, 150cm green striped tubing line
INS8302

  • Ventricular cerebrospinal fluid drainage catheterization kit
  • Lumbar cerebrospinal fluid drainage catheterization kit
External fixation system for dorsal fracture dislocations of the PIP joint.
Hand Biomechanics Lab Inc
PFX-426
In Commercial Distribution

  • 00861994000243 ()
PFX-426

  • Orthopaedic bone pin, non-bioabsorbable
Audio Processor Accessory
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38584
In Commercial Distribution

  • 09008737385842 ()


  • Cochlear implant system external kit
Audio Processor Accessory
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38303
In Commercial Distribution

  • 09008737383039 ()


  • Cochlear implant system external kit
Audio Processor Accessory
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38301
In Commercial Distribution

  • 09008737383015 ()


  • Cochlear implant system external kit
Audio Processor Accessory
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38302
In Commercial Distribution

  • 09008737383022 ()


  • Cochlear implant system external kit
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
Dandy Scan body, by CoreMedTech, for dental Intraoral scanning. This product is made of Titanium for durability with a light-dispersing surface to maximize scanning efficacy.
Coremedtech ApS
BEG, ZimVie - External Ø6.0
In Commercial Distribution

  • 05744003810086 ()
80610177

  • Dental implant abutment analog, intraoral-scanning, single-use
Dandy Scan body, by CoreMedTech, for dental Intraoral scanning. This product is made of Titanium for durability with a light-dispersing surface to maximize scanning efficacy.
Coremedtech ApS
BEY, ZimVie - External Ø5.0
In Commercial Distribution

  • 05744003810079 ()
80610176

  • Dental implant abutment analog, intraoral-scanning, single-use
Dandy Scan body, by CoreMedTech, for dental Intraoral scanning. This product is made of Titanium for durability with a light-dispersing surface to maximize scanning efficacy.
Coremedtech ApS
BE4, ZimVie - External Ø4.0
In Commercial Distribution

  • 05744003810062 ()
80610175

  • Dental implant abutment analog, intraoral-scanning, single-use
Dandy Scan body, by CoreMedTech, for dental Intraoral scanning. This product is made of Titanium for durability with a light-dispersing surface to maximize scanning efficacy.
Coremedtech ApS
BEB, ZimVie - External Ø3.75
In Commercial Distribution

  • 05744003810055 ()
80610174

  • Dental implant abutment analog, intraoral-scanning, single-use
Dandy Scan body, by CoreMedTech, for dental Intraoral scanning. This product is made of Titanium for durability with a light-dispersing surface to maximize scanning efficacy.
Coremedtech ApS
BEP, ZimVie - External Ø3.25
In Commercial Distribution

  • 05744003810048 ()
80610173

  • Dental implant abutment analog, intraoral-scanning, single-use
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
External Penile Rigidity Device that contains kit bag, manual vacuum pump, constriction rings, cylinder, lubricant, cylinder inserts, loading cone.
AUGUSTA MEDICAL SYSTEMS, L.L.C.
External Penile Rigidity Device
In Commercial Distribution

  • 00852598007189 ()


  • Penile vacuum device
External Penile Rigidity Device that contains kit bag, manual vacuum pump, battery vacuum pump, constriction rings, standard cylinder, insert cylinders, cylinder inserts, loading cone, lubricant and 9 volt battery
AUGUSTA MEDICAL SYSTEMS, L.L.C.
External Penile Rigidity Device
In Commercial Distribution

  • 00852598007172 ()


  • Penile vacuum device
External Penile Rigidity Device that contains kit bag, manual vacuum pump, constriction rings, cylinder, insert cylinders, cylinder inserts, loading cone, lubricant and standard cylinder
AUGUSTA MEDICAL SYSTEMS, L.L.C.
External Penile Rigidity Device
In Commercial Distribution

  • 00852598007165 ()


  • Penile vacuum device
External Penile Rigidity Device that contains kit bag, manual vacuum pump, battery vacuum pump,constriction rings, cylinder, lubricant, comfort inserts, loading cone, 9 volt battery.
AUGUSTA MEDICAL SYSTEMS, L.L.C.
External Penile Rigidity Device
In Commercial Distribution

  • 00852598007158 ()


  • Penile vacuum device
External Penile Rigidity Device that contains kit bag, battery vacuum pump, constriction rings, cylinder, lubricant, comfort inserts, loading cone, 9 volt battery.
AUGUSTA MEDICAL SYSTEMS, L.L.C.
External Penile Rigidity Device
In Commercial Distribution

  • 00852598007141 ()


  • Penile vacuum device
Manual Operated device that contains kit bag, manual vacuum pump, constriction rings, cylinder, lubricant, comfort inserts, loading cone.
AUGUSTA MEDICAL SYSTEMS, L.L.C.
External Penile Rigidity Device
In Commercial Distribution

  • 00852598007134 ()


  • Penile vacuum device
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