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Neurosign 800

FDA UDI

Class II (US FDA UDI)

by The Magstim Company , Ltd.

Identity

Trade Name
Neurosign 800 FDA UDI
Generic Name
Nerve-locating system FDA UDI
Device Name
Intraoperative nerve monitor FDA UDI
Model / Reference
1402-00 FDA UDI
Description
Intraoperative nerve monitor FDA UDI

Identifiers

Primary DI / UDI-DI
05060229530103 FDA UDI
510(k) Number
K053141 FDA UDI
K964869 FDA UDI
K980148 FDA UDI
FDA Product Code
ETN FDA UDI
GMDN Term
Nerve-locating system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.1820 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Neurosign 800 by The Magstim Company , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 0bd3c820-c411-4f85-8fc9-fe8b333208fe 36 fields · synced May 30, 2026