Identity
- Trade Name
- LoFric® Sense™ FDA UDI
- Generic Name
- Single-administration urethral catheterization kit, single-use FDA UDI
- Device Name
- Single Use Urinary Catheter with salt solution. LoFric Sense, Nelaton 15cm CH08 / Nelaton 6" 08FR, 5 pack. For females. Sterile device. FDA UDI
- Model / Reference
- 4160825 FDA UDI
- Description
- Single Use Urinary Catheter with salt solution. LoFric Sense, Nelaton 15cm CH08 / Nelaton 6" 08FR, 5 pack. For females. Sterile device. FDA UDI
Identifiers
- Catalog Number
- 4160805 FDA UDI
- Primary DI / UDI-DI
- 07333387021065 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
- 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 8 French FDA UDILength — 6 Inch FDA UDI
Category: Single-administration urethral catheterization kit, single-use
LoFric® Sense™ by Wellspect AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Wellspect AB
Sources (1)
- FDA UDI 52651cdd-ad1b-4c9e-9486-c95d7e62164d 37 fields · synced May 30, 2026