Catalog Number

-

Brand Name

ProGear

Version/Model Number

910134-1

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LYU

Product Code Name

Accessory, Surgical Apparel

Public Device Record Key

0e81e49b-312b-46a2-844c-39c1465bdbec

Public Version Date

November 20, 2020

Public Version Number

1

DI Record Publish Date

November 12, 2020

Package DI Number

10852212003655

Quantity per Package

4

Contains DI Package

00852212003658

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case