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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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6cm (2 1/2") - Grey
COCHLEAR LIMITED
P1659644
In Commercial Distribution

  • 09321502050357 ()
P1659644

  • Cochlear implant/auditory brainstem implant coil
8cm (3") - Brown
COCHLEAR LIMITED
P1659643
In Commercial Distribution

  • 09321502050340 ()
P1659643

  • Cochlear implant/auditory brainstem implant coil
6cm (2 1/2") - Brown
COCHLEAR LIMITED
P1659642
In Commercial Distribution

  • 09321502050333 ()
P1659642

  • Cochlear implant/auditory brainstem implant coil
8cm (3") -Black
COCHLEAR LIMITED
P1659641
In Commercial Distribution

  • 09321502050326 ()
P1659641

  • Cochlear implant/auditory brainstem implant coil
6cm (2 1/2 ") - Black
COCHLEAR LIMITED
P1659640
In Commercial Distribution

  • 09321502050319 ()
P1659640

  • Cochlear implant/auditory brainstem implant coil
8cm (3")
COCHLEAR LIMITED
P1659639
In Commercial Distribution

  • 09321502050302 ()
P1659639

  • Cochlear implant/auditory brainstem implant coil
6cm (2 1/2 ")
COCHLEAR LIMITED
P1659618
In Commercial Distribution

  • 09321502050296 ()
P1659618

  • Cochlear implant/auditory brainstem implant coil
The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 5F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
700-500DX
In Commercial Distribution

  • M729700500DX1 ()
  • M729700500DX0 ()
  • M729700500DX3 ()

  • Catheter Gauge: 5 French


  • Femoral artery closure plug/patch, collagen
The CraniSeal Dural Sealant is indicated for use in patients greater than or equal to 18 years of age as an adjunct to sutured dural repair during cranial surgery to provide a watertight closure.
Pramand LLC
CS-2055
In Commercial Distribution

  • 00860010683712 ()
  • 00860010683705 ()

  • Total Volume: 5 Milliliter
CS-2055

  • Dura mater sealant
The Model 2403-60 Transmit Coil is a non-sterile external component for use by the patient. The Transmit Coil is placed over the Rechargeable Neuroregulator (RNR) and attached to the Mobile Charger to provide a radio frequency link with the RNR for charging and communication.
Reshape Lifesciences Inc.
2403-60
Not in Commercial Distribution

  • 00857334004323 ()

  • Outer Diameter: 5 Inch
2403-60

  • Vagus nerve electrical stimulation system programmer
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