Catalog Number

RR-300SM

Brand Name

Protexter

Version/Model Number

RR-300SM

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)

-

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

70421a95-125c-4b28-9020-516ca181d3a6

Public Version Date

August 12, 2022

Public Version Number

2

DI Record Publish Date

July 28, 2022

Package DI Number

10813360022059

Quantity per Package

10

Contains DI Package

00813360022052

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag