Identity
- Trade Name
- NESS L300-Plus System FDA UDI
- Generic Name
- Gait-enhancement electrical stimulation system, external FDA UDI
- Device Name
- L300 Plus US System Kit, Left (regular) FDA UDI
- Model / Reference
- L3P-5001 FDA UDI
- Description
- L300 Plus US System Kit, Left (regular) FDA UDI
Identifiers
- Catalog Number
- 501-00122-01 FDA UDI
- Primary DI / UDI-DI
- 07290110483005 FDA UDI
- FDA Product Code
- IPF FDA UDI
- GMDN Term
- Gait-enhancement electrical stimulation system, external FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5850 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
NESS L300-Plus System by Bioness Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 c0926796-13ad-451c-978e-3a1ec5ddfb82 37 fields · synced Jun 1, 2026