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Cortac®

FDA UDI

Class II (US FDA UDI)

by Pmt Corp.

Identity

Trade Name
CORTAC® FDA UDI
Generic Name
Cortical electrode FDA UDI
Device Name
SUBDURAL GRID ELECTRODE, PLATINUM, 8X4 CORTICAL GRID, CORNER TAIL EXIT, 3MM CONTACTS, 10MM CTC, #1 CONTACT RADIOPAQUE, ALL CONTACTS NUMBERED, 0.50MM THICK, 1 EXIT, TWO-58CM LONG INLINE TAILS FDA UDI
Model / Reference
2110-32-005 FDA UDI
Description
SUBDURAL GRID ELECTRODE, PLATINUM, 8X4 CORTICAL GRID, CORNER TAIL EXIT, 3MM CONTACTS, 10MM CTC, #1 CONTACT RADIOPAQUE, ALL CONTACTS NUMBERED, 0.50MM THICK, 1 EXIT, TWO-58CM LONG INLINE TAILS FDA UDI

Identifiers

Primary DI / UDI-DI
00650551005476 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.

Cleared under the same submission

K082474 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pmt Corp.

Sources (1)

  • FDA UDI f7bf0f9b-e3b0-4db9-be12-b2035b43b8e6 36 fields · synced Jun 8, 2026