Catalog Number

-

Brand Name

C.M.P. Cable

Version/Model Number

C5010PF

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K983097

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

770bbf38-e2c7-4bd9-977d-a477ec79a808

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

October 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-