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Na 0364

by Medtronic Xomed, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number00681490017909 UDI-DI Date15 Jun 2015ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Ossicular prosthesis, partial
Model / Reference
0364
Primary DI / UDI-DI
00681490017909
510(k) Number
FDA Product Code
ETA
GMDN Term
Ossicular prosthesis, partial
Device Class
Class II
Regulation Number
874.3495
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Length — 5.0 Millimeter

Related devices

Category: Ossicular prosthesis, partial

Cleared under the same submission (K885201)

Show all (12)

Other devices from Medtronic Xomed, Inc.

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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