Skip to content

Luja Soft 20172

by Coloplast A/S

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number05701780348348 UDI-DI Date1 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Luja Soft
Generic Name
Single-administration urethral drainage catheter
Model / Ref / Catalog
20172
Primary DI / UDI-DI
05701780348348
510(k) Number
FDA Product Code
EZD
GMDN Term
Single-administration urethral drainage catheter
Device Class
Class II
Regulation Number
876.5130
GUDID distribution status
In Commercial Distribution
Size
Catheter Working Length — 327 Millimeter
Catheter Gauge — 12 French
Catheter Working Length — 33 Centimeter
Catheter Working Length — 13.0 Inch

Related devices

Cleared under the same submission (K262045)

Other devices from Coloplast A/S

See all devices from Coloplast A/S →

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