Identity
- Trade Name
- Bio Protech FDA UDI
- Generic Name
- Transcutaneous electrical stimulation lead FDA UDI
- Device Name
- LWSBR48(N)- Leadwires, 2 sets, 48'' long, Safety Plug, Black and Red Coloring, 500 sets/ in a case FDA UDI
- Model / Reference
- LWSBR48(N) FDA UDI
- Description
- LWSBR48(N)- Leadwires, 2 sets, 48'' long, Safety Plug, Black and Red Coloring, 500 sets/ in a case FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817120020456 FDA UDI
- FDA Product Code
- IKD FDA UDI
- GMDN Term
- Transcutaneous electrical stimulation lead FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1175 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Transcutaneous electrical stimulation lead
Bio Protech by Bio Protech Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Transcutaneous electrical stimulation lead.
- C.M.P. Cable — C.M.P. Canadian Medical Products Inc · Class II
- C.M.P. Cable — C.M.P. Canadian Medical Products Inc · Class II
- C.M.P. Cable — C.M.P. Canadian Medical Products Inc · Class II
- Famidoc — FAMIDOC USA, INC. · Class II
- C.M.P. Cable — C.M.P. Canadian Medical Products Inc · Class II
- Avazzia — Avazzia, Inc. · Class II
- C.M.P. Cable — C.M.P. Canadian Medical Products Inc · Class II
- C.M.P. Cable — C.M.P. Canadian Medical Products Inc · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bio Protech Usa, Inc.
Sources (1)
- FDA UDI 3b9393e9-e941-414c-87a5-0d13a50a8769 34 fields · synced May 30, 2026