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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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Cochlear™ Nucleus® CI612 cochlear implant with Contour Advance® electrode - 09321502036818

N/A
COCHLEAR LIMITED
P774600
In Commercial Distribution

  • 09321502036818 ()
P774600

  • Cochlear implant system electrode array assembly

THORATEC® PVAD™, ATRIAL CANNULA - SHORT, BEVELED TIP WITH SIDE HOLES - 00813024012115

No Description
Thoratec Corporation
10075-2574-001
In Commercial Distribution

  • 00813024012115 ()
10075-2574-001

  • External ventricular circulatory assist system

THORATEC® PVAD™, ATRIAL CANNULA - LONG, BEVELED TIP WITH SIDE HOLES - 00813024012108

No Description
Thoratec Corporation
10075-2573-001
In Commercial Distribution

  • 00813024012108 ()
10075-2573-001

  • External ventricular circulatory assist system

MENTOR Diaphragm Valve Fill Tube LONG 61cm 24in with 45 Degree Connector - 00081317009054

DV Fill Tube
MENTOR TEXAS L.P.
600975-004
In Commercial Distribution

  • 00081317009054 ()
600975-004

  • Saline-filled breast implant, unstructured, smooth-surface

Cochlear™ Nucleus® Nexa™ cochlear implant with Slim 20 electrode - 09321502053105

Cochlear Implant
COCHLEAR LIMITED
CI1024
In Commercial Distribution

  • 09321502053105 ()
P1549674

  • Cochlear implant system electrode array assembly

Cochlear™ Nucleus® Nexa™ cochlear implant with Slim Modiolar electrode - 09321502053099

Cochlear Implant
COCHLEAR LIMITED
CI1032
In Commercial Distribution

  • 09321502053099 ()
P1434929

  • Cochlear implant system electrode array assembly

Cochlear™ Nucleus® Nexa™ cochlear implant with Slim Straight electrode - 09321502053082

Cochlear Implant
COCHLEAR LIMITED
CI1022
In Commercial Distribution

  • 09321502053082 ()
Z334204

  • Cochlear implant system electrode array assembly

Nucleus - 09321502032322

Cochlear EAC200 Series Screwdriver
COCHLEAR LIMITED
FUZ1026
In Commercial Distribution

  • 09321502032322 ()
FUZ1026

  • Cochlear implant system

Mi1250 SYNCHRONY 2 PIN FLEX34 S-Vector Magnet - 09008737415433

Cochlear Implant
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
41543
In Commercial Distribution

  • 09008737415433 ()
41547

  • Cochlear implant system

SONNET 2 EAS Me1520 (w/o Magnet BAT) beige - 09008737401078

Audio Processor
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
40107
In Commercial Distribution

  • 09008737401078 ()


  • Cochlear implant/auditory brainstem implant sound processor
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