Identity
- Trade Name
- Uroval FDA UDI
- Generic Name
- Analytical non-scalp cutaneous lead FDA UDI
- Device Name
- 6' Electrode Lead Wire Set for use with the Uroval BRS System. FDA UDI
- Model / Reference
- BR5338 UDI Not Req as is component FDA UDI
- Description
- 6' Electrode Lead Wire Set for use with the Uroval BRS System. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852523007024 FDA UDI
- FDA Product Code
- IKN FDA UDI
- GMDN Term
- Analytical non-scalp cutaneous lead FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1375 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 6 Feet FDA UDI
Category: Analytical non-scalp cutaneous lead
Uroval by Uroval — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Analytical non-scalp cutaneous lead.
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- Ambu Neuroline Concentric Cable, Lenght of leadwire: 200 cm (79") — Ambu A/S · Class II
- Rhythmlink® — Rhythmlink International, LLC · Class II
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
- Uroval
Sources (1)
- FDA UDI 2a70180b-8083-4871-9c06-0425e10547fc 34 fields · synced May 30, 2026