Keypoint - Hush™ Reusable Shielded Cable for EMG and IOM - NATUS MANUFACTURING LIMITED

Duns Number:896421240

Device Description: Hush™ Reusable Shielded Cable for EMG and IOM 2x0.7mm female touchproof, 2.0m (79"), 5-pin Hush™ Reusable Shielded Cable for EMG and IOM 2x0.7mm female touchproof, 2.0m (79"), 5-pin DIN, 1/pkg

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More Product Details

Catalog Number

9013C0142

Brand Name

Keypoint

Version/Model Number

9013C0142

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

c82c4225-40c3-4db8-abac-3a4ebfe24bff

Public Version Date

October 26, 2020

Public Version Number

2

DI Record Publish Date

March 13, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NATUS MANUFACTURING LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 154