Skip to content

Siemens HA PURE CARAT+ XCL 501 DKC

by WS Audiology USA, 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04046355592247 UDI-DI Date6 May 2016ListedStatusListed 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  • Withdrawn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

Trade Name
Siemens
Generic Name
Air-conduction hearing aid, behind-the-ear
Model / Ref / Catalog
HA PURE CARAT+ XCL 501 DKC, 10673461
Primary DI / UDI-DI
04046355592247
FDA Product Code
OSM
GMDN Term
Air-conduction hearing aid, behind-the-ear
Device Class
Class II
Regulation Number
874.3305
GUDID distribution status
Not in Commercial Distribution

Other devices from WS Audiology USA, Inc.

See all devices from WS Audiology USA, Inc. →

Properties

  • Prescription Use
  • Premarket Exempt
  • Serial Number

Other properties (11)

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