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Leadpoint

FDA UDI

Class II (US FDA UDI)

by Natus Manufacturing Limited

Identity

Trade Name
Leadpoint FDA UDI
Generic Name
Neurophysiologic monitoring system FDA UDI
Device Name
Leadpoint Focus Notebook, US FDA UDI
Model / Reference
9033A0811AA FDA UDI
Description
Leadpoint Focus Notebook, US FDA UDI

Identifiers

Catalog Number
9033A0811AA FDA UDI
Primary DI / UDI-DI
00382830049290 FDA UDI
510(k) Number
K140680 FDA UDI
FDA Product Code
GZL FDA UDI
GMDN Term
Neurophysiologic monitoring system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1330 FDA UDI
Commercial Distribution
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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Neurophysiologic monitoring system

Leadpoint by Natus Manufacturing Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Neurophysiologic monitoring system.

Cleared under the same submission

K140680 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Natus Manufacturing Limited

Sources (1)

  • FDA UDI f42b2dd2-49be-4ea4-922a-43b0650c7e28 35 fields · synced Jun 1, 2026