Catalog Number

PC90035

Brand Name

Uni-Patch

Version/Model Number

PC90035

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

fef5eff0-9c6d-48d6-ba7a-a5782e9e3906

Public Version Date

February 19, 2021

Public Version Number

6

DI Record Publish Date

July 24, 2017

Package DI Number

90884521171387

Quantity per Package

300

Contains DI Package

10884521171381

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE