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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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M Earhook - 00840094447721

Small with grip
Advanced Bionics, LLC
CI-5711-200
In Commercial Distribution



  • Cochlear implant/auditory brainstem implant sound processor earhook

Avive AED with Avive Connect - 00860002508559

No Description
Avive Solutions, Inc.
AED01
In Commercial Distribution

  • 00860002508559 ()


  • Rechargeable public automated external defibrillator

BATTERY, LI-ION, WITH IFU, LP35 - 00883873790144

BATTERY, LI-ION, LP35
PHYSIO-CONTROL, INC.
11335
In Commercial Distribution

  • 00883873790144 ()
11335-000001

  • Portable/mobile rechargeable battery pack

Surface Electrode, 4-pack with Interconnect - 00852184003458

No Description
Synapse Biomedical, Inc.
22-0034
In Commercial Distribution

  • 00852184003458 ()


  • Percutaneous electrical stimulation lead external pulse generator cable, reusable

Smart Spot with CPR4BR accessory - 08031527018089

MicroPort Smart Spot (IMV2+) / CPR4BR adapter
MICROPORT CRM SRL
KC861
In Commercial Distribution

  • 08031527018089 ()
KC861

  • Medical networking interface unit

coflex Trial with lower wings - 04260148898860

No Description
Paradigm Spine GmbH
UDT10007
In Commercial Distribution

  • 04260148898860 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

coflex Trial with upper wings - 04260148898853

No Description
Paradigm Spine GmbH
UDT00007
In Commercial Distribution

  • 04260148898853 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

coflex Trial with wings, 16mm - 04260148898846

No Description
Paradigm Spine GmbH
UCT00016
In Commercial Distribution

  • 04260148898846 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

coflex Trial with wings, 14mm - 04260148898839

No Description
Paradigm Spine GmbH
UCT00014
In Commercial Distribution

  • 04260148898839 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

coflex Trial with wings, 12mm - 04260148898822

No Description
Paradigm Spine GmbH
UCT00012
In Commercial Distribution

  • 04260148898822 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
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