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XactStrip

FDA UDI

Class II (US FDA UDI)

by Blackrock Microsystems

Identity

Trade Name
XactStrip FDA UDI
Generic Name
Cortical electrode FDA UDI
Device Name
XactStrip, 6 Contact, Platinum, Reinforcement, 1x6, 10mm Spacing FDA UDI
Model / Reference
028934 FDA UDI
Description
XactStrip, 6 Contact, Platinum, Reinforcement, 1x6, 10mm Spacing FDA UDI

Identifiers

Catalog Number
028934 FDA UDI
Primary DI / UDI-DI
00814901020780 FDA UDI
510(k) Number
K191346 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Cortical electrode

XactStrip 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

K191346 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Blackrock Microsystems

Sources (1)

  • FDA UDI 0f75e848-f813-455d-9369-19100a49b9a1 37 fields · synced May 30, 2026