Catalog Number

EP85350

Brand Name

Uni-Patch

Version/Model Number

EP85350

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

-

Product Code

GXY

Product Code Name

ELECTRODE, CUTANEOUS

Public Device Record Key

95b9a77e-ae8c-4742-ab7f-52f95940fef3

Public Version Date

February 19, 2021

Public Version Number

8

DI Record Publish Date

September 24, 2016

Package DI Number

90884521168318

Quantity per Package

800

Contains DI Package

10884521168312

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE