Modular Electrode Interface-PM10 - Modular Electrode Interface for connecting 10 - NEURALYNX, INC.

Duns Number:933200842

Device Description: Modular Electrode Interface for connecting 10 contact PMT MINI CONNECTOR to Modular Headst Modular Electrode Interface for connecting 10 contact PMT MINI CONNECTOR to Modular Headstage-36 which is connected to the ATLAS Acquisition Amplifier. Modular Electrode Interface-PM10 and Modular Headstage-36 are components of the ATLAS Neurophysiology System.

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More Product Details

Catalog Number

31-0603-0022

Brand Name

Modular Electrode Interface-PM10

Version/Model Number

MEI-PM10

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

8588611f-3182-4a0e-b44c-ad24671db7b0

Public Version Date

November 15, 2021

Public Version Number

1

DI Record Publish Date

November 05, 2021

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