Catalog Number

382963

Brand Name

Regard™

Version/Model Number

A3SRGST3X-REG

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

FYA

Product Code Name

Gown, Surgical

Public Device Record Key

3de70164-220c-4ff4-90a8-d47335b20e10

Public Version Date

April 20, 2021

Public Version Number

4

DI Record Publish Date

September 10, 2020

Package DI Number

10326053117593

Quantity per Package

24

Contains DI Package

00326053117596

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-