Identity
- Trade Name
- CORTAC FDA UDI
- Generic Name
- Cortical electrode FDA UDI
- Device Name
- PLATINUM GRID ELECTRODE, 48 MACRO CONTACTS, 6X8, SMOOTH INLINE CONNECTOR, 3 EXIT, 3 LEAD, 3 TAIL FDA UDI
- Model / Reference
- 2100-48-002M2 FDA UDI
- Description
- PLATINUM GRID ELECTRODE, 48 MACRO CONTACTS, 6X8, SMOOTH INLINE CONNECTOR, 3 EXIT, 3 LEAD, 3 TAIL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00650551148838 FDA UDI
- 510(k) Number
- K082474 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cortical electrode
Cortac by Pmt Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cortical electrode.
- Subdural Electrode — Ad-Tech Medical Instrument Corp. · Class II
- Subdural Electrode — Ad-Tech Medical Instrument Corp. · Class II
- CORTAC® — Pmt Corp. · Class II
- CORTAC® — Pmt Corp. · Class II
- CORTAC® — Pmt Corp. · Class II
- CORTAC® — Pmt Corp. · Class II
- CORTAC® — Pmt Corp. · Class II
- CORTAC® — Pmt Corp. · Class II
Cleared under the same submission
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
- Pmt Corp.
Sources (1)
- FDA UDI 73e8392a-7062-4f80-8306-2195fb1adb47 34 fields · synced Jun 8, 2026