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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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Mi1000 MED-EL CONCERT +FLEX28 - 09008737083632

Cochlear Implant
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
08363
Not in Commercial Distribution

  • 09008737083632 ()
08842

  • Cochlear implant system electrode array assembly

Mi1000 MED-EL CONCERT PIN +FLEX28 - 09008737083625

Cochlear Implant
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
08362
Not in Commercial Distribution

  • 09008737083625 ()
08841

  • Cochlear implant system electrode array assembly

SONATATI100 +FLEX28 - 09008737083618

Cochlear Implant
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
08361
Not in Commercial Distribution

  • 09008737083618 ()


  • Cochlear implant system electrode array assembly

ColoSense Collection Kit - 00198715728941

Device is a stool collection kit for at-home use.
Geneoscopy, Inc.
0
In Commercial Distribution

  • 00198715728941 ()


  • Faecal specimen collection kit IVD, home-use

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

Cochlear™ Nucleus® CI632 cochlear implant with Slim Modiolar electrode - 09321502036580

N/A
COCHLEAR LIMITED
P783831
In Commercial Distribution

  • 09321502036580 ()
P783831

  • Cochlear implant system electrode array assembly

Cochlear™ Nucleus® CI622 cochlear implant with Slim Straight electrode - 09321502036573

N/A
COCHLEAR LIMITED
P783829
In Commercial Distribution

  • 09321502036573 ()
P783829

  • Cochlear implant system electrode array assembly

GUARDIAN® - 00613994418258

MONITOR CSS7100NAR GRDN RLTIME EN RPL
MEDTRONIC MINIMED, INC.
CSS7100NAR
In Commercial Distribution

  • 00613994418258 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical

GUARDIAN® - 00613994418241

MONITOR CSS7100KNAR GRDN RLTM PED EN RPL
MEDTRONIC MINIMED, INC.
CSS7100KNAR
Not in Commercial Distribution

  • 00613994418241 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical

CGMS® iPro™ - 00613994417992

RCDR MMT-7709NA CGMS IPRO V1.0 EN RPL
MEDTRONIC MINIMED, INC.
MMT-7709NA
In Commercial Distribution

  • 00613994417992 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
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