Identity
- Trade Name
- NeuroPort Electrode (SIROF) FDA UDI
- Generic Name
- Cortical electrode FDA UDI
- Device Name
- NeuroPort Electrode (SIROF) 1.5mm FDA UDI
- Model / Reference
- 6248 FDA UDI
- Description
- NeuroPort Electrode (SIROF) 1.5mm FDA UDI
Identifiers
- Catalog Number
- 6248 FDA UDI
- Primary DI / UDI-DI
- 00814901020025 FDA UDI
- 510(k) Number
- K110010 FDA UDI
- FDA Product Code
- GZL FDA UDI
- GMDN Term
- Cortical electrode FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1330 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 1.5 Millimeter FDA UDI
Category: Cortical electrode
NeuroPort Electrode (SIROF) by Blackrock Microsystems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cortical electrode.
Cleared under the same submission
K110010 also covers:
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
- Blackrock Microsystems
Sources (1)
- FDA UDI 90efe771-abef-4ac6-b091-9ea5bf512d54 37 fields · synced Jun 1, 2026