XactTrode Patient Cable

FDA UDI

Class II (US FDA UDI)

by Blackrock Microsystems

Identity

Trade Name: XactTrode Patient Cable FDA UDI
Generic Name: Electroencephalographic signal amplifier FDA UDI
Device Name: XactTrode Patient Cable, 64 Contact with DIN Lead Connector, 10ft FDA UDI
Model / Reference: 028917 FDA UDI
Description: XactTrode Patient Cable, 64 Contact with DIN Lead Connector, 10ft FDA UDI

Identifiers

Catalog Number: 028917 FDA UDI
Primary DI / UDI-DI: 00814901021251 FDA UDI
510(k) Number: K191346 FDA UDI
FDA Product Code: IKD FDA UDI
GMDN Term: Electroencephalographic signal amplifier FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.1175 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 10 Feet FDA UDI

Category: Electroencephalographic signal amplifier

XactTrode Patient Cable is a high-impedance, DIN Lead Connector-based electroencephalographic (EEG) amplifier designed for clinical and research settings. This XactTrode device is engineered to provide a safe and reliable solution for amplifying brain signals, making it an ideal choice for patients undergoing neuroimaging procedures or those requiring precise EEG monitoring.

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Cleared under the same submission

K191346 also covers:

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: Blackrock Microsystems

Sources (1)

FDA UDI 9aef6a31-2861-45f7-8e5a-cf792da49e3a 37 fields · synced Jul 24, 2026