NATUS NEUROLOGY INCORPORATED - CT+ II MAIN UNIT - NATUS NEUROLOGY INCORPORATED

Duns Number:874257488

Device Description: CT+ II MAIN UNIT

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More Product Details

Catalog Number

-

Brand Name

NATUS NEUROLOGY INCORPORATED

Version/Model Number

XLT009

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

K942441

Product Code Details

Product Code

JAF

Product Code Name

Monitor, Ultrasonic, Nonfetal

Device Record Status

Public Device Record Key

6e00f240-d3d1-440e-a379-6bd08a322394

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 21, 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