Catalog Number

ES82060

Brand Name

Uni-Patch

Version/Model Number

ES82060

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

Yes

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

GXY

Product Code Name

ELECTRODE, CUTANEOUS

Public Device Record Key

1e06814d-99ce-499c-a35e-90ed5937ec4f

Public Version Date

February 19, 2021

Public Version Number

8

DI Record Publish Date

September 24, 2016

Package DI Number

90884521167953

Quantity per Package

1600

Contains DI Package

10884521167957

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE