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Bioness L300 Go Hydrogel Electrodes Set
FDA UDIClass II (US FDA UDI)
by Bioness Inc.
Identity
- Trade Name
- Bioness L300 Go Hydrogel Electrodes Set FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, reusable FDA UDI
- Device Name
- Hydrogel Electrode Set FDA UDI
- Model / Reference
- LG3-5F00 FDA UDI
- Description
- Hydrogel Electrode Set FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815962020078 FDA UDI
- FDA Product Code
- IPF FDA UDIGZI FDA UDI
- GMDN Term
- Transcutaneous electrical stimulation electrode, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5850 FDA UDI882.5810 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
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
Category: Transcutaneous electrical stimulation electrode, reusable
Bioness L300 Go Hydrogel Electrodes Set by Bioness Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Transcutaneous electrical stimulation electrode, reusable.
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- ManaFlexx 2 Electrodes - 4 electrodes — MANAMED 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
- Bioness Inc.
Sources (1)
- FDA UDI c835a12a-ba40-4aa6-b557-d8dee3e2c8ea 34 fields · synced Jun 1, 2026