Natus - SOFT/EEG NICOLET-ONEV4.1.3B971 - NATUS NEUROLOGY INCORPORATED

Duns Number:874257488

Device Description: SOFT/EEG NICOLET-ONEV4.1.3B971

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More Product Details

Catalog Number

-

Brand Name

Natus

Version/Model Number

482-637405

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GWQ

Product Code Name

Full-Montage Standard Electroencephalograph

Device Record Status

Public Device Record Key

ce7bb7a2-e410-420a-a2ad-4762e9f142c5

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 14, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NATUS NEUROLOGY INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 364