Catalog Number

9013S0402

Brand Name

Keypoint

Version/Model Number

9013S0402

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K934580

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

a1277d6e-41ad-479d-9e0a-eb4bb8491b55

Public Version Date

October 16, 2020

Public Version Number

2

DI Record Publish Date

March 13, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-