Catalog Number

RR-100

Brand Name

Protexter

Version/Model Number

1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 11, 2022

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

5ee12cd5-3a63-41f5-aa2f-1747902cc19d

Public Version Date

October 28, 2022

Public Version Number

2

DI Record Publish Date

July 10, 2020

Package DI Number

10813360021649

Quantity per Package

10

Contains DI Package

00813360021642

Package Discontinue Date

August 11, 2022

Package Status

Not in Commercial Distribution

Package Type

Bag