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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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Slim HP AquaMic™ - 07630016880308

Brown
Advanced Bionics AG
CI-5321-011
In Commercial Distribution

  • 07630016880308 ()

  • Length: 24 Inch


  • Cochlear implant/auditory brainstem implant coil

Slim HP AquaMic™ - 07630016880261

Black
Advanced Bionics AG
CI-5321-010
Not in Commercial Distribution

  • 07630016880261 ()

  • Length: 24 Inch


  • Cochlear implant/auditory brainstem implant coil

Slim HP AquaMic™ - 07630016880223

Gray
Advanced Bionics AG
CI-5321-012
Not in Commercial Distribution

  • 07630016880223 ()

  • Length: 24 Inch


  • Cochlear implant/auditory brainstem implant coil

Slim HP AquaMic™ - 07630016880186

Beige
Advanced Bionics AG
CI-5321-009
Not in Commercial Distribution

  • 07630016880186 ()

  • Length: 24 Inch


  • Cochlear implant/auditory brainstem implant coil

RF Cable - 07630016839603

Brown
Advanced Bionics, LLC
CI-5415-404
Not in Commercial Distribution

  • 07630016839603 ()

  • Length: 24 Centimeter


  • Cochlear implant/auditory brainstem implant coil cable

ONYX 34 - 00847536006188

105-7100-080 ONYX 34 KIT AVM US
Micro Therapeutics, Inc.
105-7100-080
In Commercial Distribution

  • 00847536006188 ()


  • Neurovascular embolization plug

ONYX 18 - 00847536006171

105-7100-060 ONYX 18 KIT AVM US
Micro Therapeutics, Inc.
105-7100-060
In Commercial Distribution

  • 00847536006171 ()


  • Neurovascular embolization plug

Onyx 18 - 00836462005044

Liquid Embolic 105-7100-060 Onyx 18
Micro Therapeutics, Inc.
105-7100-060
In Commercial Distribution

  • 00836462005044 ()


  • Neurovascular embolization plug

Amplatzer™ - 05415067019301

Septal Occluder
AGA MEDICAL CORPORATION
9-ASD-024
In Commercial Distribution

  • 05415067019301 ()

  • Outer Diameter: 24 Millimeter
9-ASD-024

  • Cardiac defect occluder

Occlutech ASD Occluder - 04260182521656

The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device, consisting of 2 nitinol wire mesh discs connected by a waist section and polyethylene terephthalate (PET) patches. The PET patches, sewn into the wire mesh, are intended to stop the blood flow through the ASD as well as optimize tissue growth. The design properties of the Occlutech ASD Occluder allow transcatheter implant of the device. The Occlutech ASD Occluder is packaged with its compatible Occlutech Pistol Pusher (OPP), Instructions for Use (IFU) and Patient Implant Card.
Occlutech GmbH
37ASD24
In Commercial Distribution

  • 04260182521656 ()

  • Outer Diameter: 24 Millimeter
37ASD24

  • Cardiac defect occluder
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