Catalog Number

-

Brand Name

ProGear

Version/Model Number

GN22010

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

FME

Product Code Name

Gown, Examination

Public Device Record Key

86a03018-8646-4119-9758-61898623e5d3

Public Version Date

September 25, 2019

Public Version Number

1

DI Record Publish Date

September 17, 2019

Package DI Number

10852212003563

Quantity per Package

1

Contains DI Package

00852212003566

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case