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Blackrock NeuroPort Biopotential Signal Processing System

FDA UDI

Class II (US FDA UDI)

by Blackrock Microsystems

Identity

Trade Name
Blackrock NeuroPort Biopotential Signal Processing System FDA UDI
Generic Name
Electrical-only medical device connection cable, reusable FDA UDI
Device Name
Patient Cable with Impedance Tester FDA UDI
Model / Reference
4460 FDA UDI
Description
Patient Cable with Impedance Tester FDA UDI

Identifiers

Catalog Number
4460 FDA UDI
Primary DI / UDI-DI
00814901020100 FDA UDI
510(k) Number
K090957 FDA UDI
FDA Product Code
GWL FDA UDI
GMDN Term
Electrical-only medical device connection cable, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1835 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Blackrock NeuroPort Biopotential Signal Processing System by Blackrock Microsystems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K090957 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 9a3e3c60-bbc4-43c3-9c61-a53ab624b409 37 fields · synced Jun 8, 2026