Catalog Number

EP84590

Brand Name

Uni-Patch

Version/Model Number

EP84590

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 17, 2021

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

260bddca-dfe2-4a51-a1cd-19b3e2d4f228

Public Version Date

February 19, 2021

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

90884527023062

Quantity per Package

20

Contains DI Package

10884527023066

Package Discontinue Date

February 17, 2021

Package Status

Not in Commercial Distribution

Package Type

CASE