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Cochlear® Osia® 3(I) Sound Processor base unit P2053391

by Cochlear

Listed FDA GUDID listing, no authorization on record

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 Number09321502075565 UDI-DI Date15 Jul 2026ListedStatusListed GUDID: 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  • Withdrawn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
Cochlear® Osia® 3(I) Sound Processor base unit
Generic Name
Cochlear implant/auditory brainstem implant sound processor
Catalog Number
P2053391
Primary DI / UDI-DI
09321502075565
510(k) Number
FDA Product Code
PFO
GMDN Term
Cochlear implant/auditory brainstem implant sound processor
Device Class
Class II
Regulation Number
874.3340
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K260902)

Show all (12)

Other devices from Cochlear

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Properties

  • Prescription Use
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (10)

  • 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