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Luja Set 20082

by Coloplast A/S

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05708932783323 UDI-DIDate2 Sep 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  • Withdrawn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
Luja Set
Generic Name
Single-administration urethral catheterization kit, single-use
Model / Ref / Catalog
20082
Primary DI / UDI-DI
05708932783323
510(k) Number
FDA Product Code
EZD, FCM
GMDN Term
Single-administration urethral catheterization kit, single-use
Device Class
Class II
Regulation Number
876.5130
GUDID distribution status
In Commercial Distribution
Size
Catheter Working Length — 13 Inch
Catheter Working Length — 33 Centimeter
Catheter Gauge — 12 French

Related devices

Cleared under the same submission (K250270)

Other devices from Coloplast A/S

See all devices from Coloplast A/S →

Properties

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

Other properties (8)

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