Identity
- Trade Name
- CERVELLO STIM FDA UDI
- Generic Name
- Cortical electrode FDA UDI
- Device Name
- Cortical / Intracranial Stimulator to be combined with CERVELLO 64 Series Amplifiers FDA UDI
- Model / Reference
- NM-0353 FDA UDI
- Description
- Cortical / Intracranial Stimulator to be combined with CERVELLO 64 Series Amplifiers FDA UDI
Identifiers
- Catalog Number
- NM-0353 FDA UDI
- Primary DI / UDI-DI
- 00850154007062 FDA UDI
- FDA Product Code
- GYC FDA UDI
- GMDN Term
- Cortical electrode FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1310 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cortical electrode
Cervello Stim by Blackrock Neuromed, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cortical electrode.
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
- Blackrock Neuromed, Llc
Sources (1)
- FDA UDI d0b28382-8f37-44d7-8b70-a68cb1a22810 35 fields · synced Jun 6, 2026