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LoFric Elle Pro 4191050

by Wellspect AB

Listed FDA GUDID listing, no authorization on record

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 Number07333387055695 UDI-DI Date20 May 2026ListedStatusListed GUDID: 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  • Withdrawn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
LoFric Elle Pro
Generic Name
Intermittent urethral drainage catheter, non-antimicrobial, single-use
Model / Reference
4191050
Primary DI / UDI-DI
07333387055695
FDA Product Code
EZD
GMDN Term
Intermittent urethral drainage catheter, non-antimicrobial, single-use
Device Class
Class II
Regulation Number
876.5130
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 10 French
Catheter Length — 4 Inch

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

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