Catalog Number

-

Brand Name

HEPRO.US Reinforced Surgical Gown L 43gsm

Version/Model Number

Single Pouch Reinforced Surgical Gown 43gsm SMMS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

9167d114-2e29-4f39-9171-a874a38554fa

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

June 20, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-