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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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VARIAX - 07613327398885

K-Wire with Stop
Stryker GmbH
705150
In Commercial Distribution

  • 07613327398885 ()

  • Length: 150.0 Millimeter
  • Diameter: 1.6 Millimeter
705150

  • Orthopaedic intraoperative positioning pin, single-use

eCardiostation Software - B147EC0

Software with CardioStation
UNIVERSAL MEDICAL, INC.
eCardiostation Software
In Commercial Distribution

  • B147EC0 ()


  • Electrocardiography telemetric monitoring system

PROS Tail - 00816299012736

Wedge with Tail
Hovertech International
PROS-TAIL
In Commercial Distribution

  • 00816299012750 ()
  • 00816299012736 ()
  • 00816299012774 ()
PROS-TAIL

  • Freestanding patient positioner, single-use

Prima - D76845009K0

Base with Anatite
KEYSTONE DENTAL, INC.
45009K
Not in Commercial Distribution

  • D76845009K0 ()

  • Outer Diameter 10.0 - 10.0 mm
45009K

  • Dental implant suprastructure, permanent, preformed

Prima - D76845008K0

Base with Anatite
KEYSTONE DENTAL, INC.
45008K
Not in Commercial Distribution

  • D76845008K0 ()

  • Outer Diameter 10.0 - 10.0 mm
45008K

  • Dental implant suprastructure, permanent, preformed

Prima - D76845007K0

Base with Anatite
KEYSTONE DENTAL, INC.
45007K
Not in Commercial Distribution

  • D76845007K0 ()

  • Outer Diameter 10.0 - 10.0 mm
45007K

  • Dental implant suprastructure, permanent, preformed

BioStamp® nPoint - G012BRCA02

Adhesive with hydrogel
Medidata Solutions, Inc.
BRCA02
In Commercial Distribution

  • G012MC0009 ()
  • G012BRCA02 ()
  • B493BRCA02 ()


  • Biomechanical function analysis/rehabilitation software
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder

M Earhook - 07630016880773

Standard with grip
Advanced Bionics AG
CI-5711-210
Not in Commercial Distribution

  • 07630016880773 ()


  • Cochlear implant/auditory brainstem implant sound processor earhook

M Earhook - 07630016880766

Small with grip
Advanced Bionics AG
CI-5711-200
Not in Commercial Distribution

  • 07630016880766 ()


  • Cochlear implant/auditory brainstem implant sound processor earhook

Earhook - 07630016851193

Standard with grip
Advanced Bionics AG
CI-5710-210
Not in Commercial Distribution

  • 07630016851193 ()


  • Cochlear implant/auditory brainstem implant sound processor
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