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Subdural Electrode

FDA UDI

Class II (US FDA UDI)

by Ad-Tech Medical Instrument Corp.

Identity

Trade Name
Subdural Electrode FDA UDI
Generic Name
Cortical electrode FDA UDI
Model / Reference
FG20C-SS10X-003 FDA UDI

Identifiers

Catalog Number
FG20C-SS10X-003 FDA UDI
Primary DI / UDI-DI
00841823102089 FDA UDI
510(k) Number
K053363 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

No

FDA UDI

Category: Cortical electrode

Subdural Electrode by Ad-Tech Medical Instrument 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

K053363 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ad-Tech Medical Instrument Corp.

Sources (1)

  • FDA UDI 4ba124d2-9df2-4d92-886b-48b86e3e7a12 36 fields · synced Jun 9, 2026