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Audio Processor 404 dark brown 11223-006

by Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number09008738501128 UDI-DI Date22 Sep 2014ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Audio Processor 404 dark brown
Generic Name
Partially-implantable middle ear implant system sound processor
Model / Reference
11223-006
Primary DI / UDI-DI
09008738501128
PMA Number
FDA Product Code
MPV
GMDN Term
Partially-implantable middle ear implant system sound processor
Device Class
Class III
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (P990052)

Show all (12)

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Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No