Catalog Number

-

Brand Name

Uniseal UniPro

Version/Model Number

702-9

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

6f4d7f5f-8066-40b0-85a9-44f78af8d47f

Public Version Date

August 30, 2022

Public Version Number

1

DI Record Publish Date

August 22, 2022

Package DI Number

30744514070296

Quantity per Package

10

Contains DI Package

20744514070299

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE