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Na 1112303

by Medtronic Xomed, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00681490033640 UDI-DIDate19 Jun 2015ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Ossicular prosthesis, total
Model / Reference
1112303
Primary DI / UDI-DI
00681490033640
510(k) Number
FDA Product Code
ETA
GMDN Term
Ossicular prosthesis, total
Device Class
Class II
Regulation Number
874.3495
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Conditional
Size
Length — 8.0 Millimeter

Related devices

Cleared under the same submission (K810707)

Show all (12)

Other devices from Medtronic Xomed, Inc.

See all devices from Medtronic Xomed, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (9)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No