Catalog Number

RR-200

Brand Name

Protexter

Version/Model Number

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)

-

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

f5220a23-df4a-4cc4-bde8-a0080a498c05

Public Version Date

October 27, 2022

Public Version Number

3

DI Record Publish Date

December 28, 2020

Package DI Number

10813360021656

Quantity per Package

10

Contains DI Package

00813360021659

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag