Catalog Number

-

Brand Name

Reinforce Surgical Gown (AAMI Level 3)

Version/Model Number

PM5005RGS

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

K210143,K210143

Product Code

FYA

Product Code Name

Gown, Surgical

Public Device Record Key

11e1245f-2334-452b-8849-d5a91ffb27a0

Public Version Date

September 08, 2021

Public Version Number

1

DI Record Publish Date

August 31, 2021

Package DI Number

16973062320199

Quantity per Package

50

Contains DI Package

06973062320192

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-