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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 STRIP ELECTRODE, STAINLESS STEEL, 6 CONTACT, 1X6, TEXTURED, INLINE CONNECTOR, 1 EXIT, MEG2, ALL CONTACTS NUMBERED FDA UDI
Model / Reference
2111TX-06-032M2-NS FDA UDI
Description
SUBDURAL STRIP ELECTRODE, STAINLESS STEEL, 6 CONTACT, 1X6, TEXTURED, INLINE CONNECTOR, 1 EXIT, MEG2, ALL CONTACTS NUMBERED FDA UDI

Identifiers

Catalog Number
2111TX-06-032M2-NS FDA UDI
Primary DI / UDI-DI
00650551083542 FDA UDI
510(k) Number
K845035 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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Hydrogen Peroxide 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

K845035 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 b8c846f7-75dc-44a8-8eac-db69a9c9323a 37 fields · synced Jun 1, 2026