Catalog Number

-

Brand Name

Reinforce Surgical Gown (AAMI Level 3)

Version/Model Number

PM5012RGN

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

Product Code

FYA

Product Code Name

Gown, Surgical

Public Device Record Key

422009a2-6fc9-43b8-a3cc-08a0ff26c1e5

Public Version Date

October 06, 2021

Public Version Number

1

DI Record Publish Date

September 28, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-