Identity
- Trade Name
- Luja FDA UDI
- Generic Name
- Single-administration urethral drainage catheter FDA UDI
- Model / Reference
- 20051 FDA UDI
Identifiers
- Catalog Number
- 20051 FDA UDI
- Primary DI / UDI-DI
- 05708932767835 FDA UDI
- 510(k) Number
- K241028 FDA UDI
- FDA Product Code
- EZD FDA UDI
- GMDN Term
- Single-administration urethral drainage catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5130 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Working Length — 9 Centimeter FDA UDICatheter Working Length — 3.5 Inch FDA UDICatheter Gauge — 10 French FDA UDI
Category: Single-administration urethral drainage catheter
Luja by Coloplast A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Single-administration urethral drainage catheter.
- CURE ULTRA MALE CATHETER — CONVATEC, PURCHASING DEPARTMENT · Class II
- Bardex® Urethral Catheter Robinson Model — C. R. Bard, Inc. · Class II
- CURE CATHETER — CONVATEC, PURCHASING DEPARTMENT · Class II
- Apogee Plus — Hollister Incorporated · Class II
- Magic3™ Intermittent Catheter — C. R. Bard, Inc. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- CURE ULTRA MALE CATHETER — CONVATEC, PURCHASING DEPARTMENT · Class II
- Bard® Rubber Utility Catheter — C. R. Bard, Inc. · Class II
Cleared under the same submission
K241028 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Coloplast A/S
Sources (1)
- FDA UDI 5096957b-c244-45f1-be74-36bed02222af 37 fields · synced Jun 8, 2026