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Na S0264-12

by Medtronic Xomed, Inc. GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00643169719798 UDI-DIDate2 Oct 2017ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Generic Name
Bone-conduction hearing aid, head-worn
Model / Reference
S0264-12
Primary DI / UDI-DI
00643169719798
510(k) Number
FDA Product Code
LXB
GMDN Term
Bone-conduction hearing aid, head-worn
Device Class
Class II
Regulation Number
874.3302
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Unsafe

Other devices from Medtronic Xomed, Inc.

See all devices from Medtronic Xomed, Inc. →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Implantable: No
  • 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