ADPT-HD-Y Adapter Cable - ADPT-HD-Y Adapter Cable for use with the ATLAS - NEURALYNX, INC.

Duns Number:933200842

Device Description: ADPT-HD-Y Adapter Cable for use with the ATLAS Neurophysiology System.

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More Product Details

Catalog Number

-

Brand Name

ADPT-HD-Y Adapter Cable

Version/Model Number

31-0602-0033

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

IKD

Product Code Name

Cable, Electrode

Device Record Status

Public Device Record Key

69cf13a0-dedd-4e9a-899a-d2545a026b44

Public Version Date

July 26, 2022

Public Version Number

1

DI Record Publish Date

July 18, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEURALYNX, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 50