Identity
- Trade Name
- LoFric® Primo™ FDA UDI
- Generic Name
- Single-administration urethral catheterization kit, single-use FDA UDI
- Device Name
- Single Use Urinary Catheter LoFric Primo Nelaton 6" 08FR FDA UDI
- Model / Reference
- 41408 FDA UDI
- Description
- Single Use Urinary Catheter LoFric Primo Nelaton 6" 08FR FDA UDI
Identifiers
- Catalog Number
- 4140840 FDA UDI
- Primary DI / UDI-DI
- 07392532135514 FDA UDI
- FDA Product Code
- EZD FDA UDI
- GMDN Term
- Single-administration urethral catheterization kit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5130 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
- Length — 6 Inch FDA UDICatheter Gauge — 8 French FDA UDI
A comprehensive 2-3 paragraph SEO description for the LoFric Primo single-use urinary catheter, highlighting its unique features, regulatory compliance, and customer support details. The description should be written in clear, natural language, avoiding raw JSON keys or structures.
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
- Wellspect AB
Sources (1)
- FDA UDI 87c8ec04-1d98-4986-82c2-483e98c46d45 38 fields · synced Jul 13, 2026