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Keypoint

FDA UDI

Class II (US FDA UDI)

by Natus Manufacturing Limited

Identity

Trade Name
Keypoint FDA UDI
Generic Name
Electromyograph FDA UDI
Device Name
Quantitative EMG for Keypoint.NET FDA UDI
Model / Reference
9033S0691 FDA UDI
Description
Quantitative EMG for Keypoint.NET FDA UDI

Identifiers

Catalog Number
9033S0691 FDA UDI
Primary DI / UDI-DI
00382830050968 FDA UDI
510(k) Number
K944547 FDA UDI
FDA Product Code
GWF FDA UDI
GMDN Term
Electromyograph FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1870 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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electromyograph

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

Similar devices

Also classified as Electromyograph.

Cleared under the same submission

K944547 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 e84dffbe-7f0d-4ebf-8101-fe1e4cf6da55 35 fields · synced May 30, 2026