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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™ Hybrid™ Power Dome, 6 mm - 09321502038485

N/A
COCHLEAR LIMITED
Z544997
In Commercial Distribution

  • 09321502038485 ()
  • 09321502043021 ()

  • Outer Diameter: 6 Millimeter
  • 6mm diameter dome
Z544997

  • Earmould, preformed

Cochlear™ Hybrid™ Power Dome, 8 mm - 09321502038478

N/A
COCHLEAR LIMITED
Z544998
In Commercial Distribution

  • 09321502038478 ()
  • 09321502043038 ()

  • 8mm diameter dome
  • Outer Diameter: 8 Millimeter
Z544998

  • Earmould, preformed

Cochlear™ Hybrid™ Power Dome, 10 mm - 09321502038447

N/A
COCHLEAR LIMITED
Z545001
In Commercial Distribution

  • 09321502038447 ()
  • 09321502043045 ()

  • 10mm diameter dome
  • Outer Diameter: 10 Millimeter
Z545001

  • Earmould, preformed

Bone Profiler - 08800293007784

Ø6
Megagen Implant Co. Ltd
ARIBP60G
In Commercial Distribution

  • 08800293007784 ()
ARIBP60G

  • Fixture/appliance dental drill bit, reusable

Paradise® Cartridge - 00810008950074

PRDS-CT-02 Paradise® Cartridge
Recor Medical, Inc.
PRDS-CT-02
In Commercial Distribution

  • 00810008950074 ()
  • 10810008950071 ()
PRDS-CT-02

  • Renal denervation ultrasound system cooling solution flow chamber

Nucleus - 09321502028059

FREEDOM MINI BTE CONTROLLER BATTERY HOLDER, BLACK
COCHLEAR LIMITED
Z61032
In Commercial Distribution

  • 09321502028059 ()
  • 09321502032018 ()
Z61032

  • Cochlear implant/auditory brainstem implant battery
  • Battery box

Aveir™ - 05415067031914

Link Module Programmer Communication Module
ST. JUDE MEDICAL, INC.
LSL02
In Commercial Distribution

  • 05415067031914 ()
LSL02

  • Intracardiac pacemaker programming interface unit

G7 POLY LINER REMOVER DRILL BIT - 00880304926936

No Description
Biomet Orthopedics, LLC
010002746
In Commercial Distribution

  • 00880304926936 ()
010002746

  • Fluted surgical drill bit, single-use

BIRMINGHAM HIP - 03596010606136

3.2MM BIRMINGHAM HIP RE-DRILL HANDLE
Smith & Nephew, Inc.
90123275
In Commercial Distribution

  • 03596010606136 ()
90123275

  • Fluted surgical drill bit, reusable

BIRMINGHAM HIP RESURFACING (BHR) - 03596010591616

ALIGNMENT GUIDE
Smith & Nephew, Inc.
90128280
In Commercial Distribution

  • 03596010591616 ()
90128280

  • Fluted surgical drill bit, reusable
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