Catalog Number

-

Brand Name

Regard™

Version/Model Number

GS00082V

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 18, 2021

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OJJ

Product Code Name

Burn Kit Without Drug

Public Device Record Key

a625f429-2162-417b-b63a-af7b3d0e4c1b

Public Version Date

June 18, 2021

Public Version Number

3

DI Record Publish Date

November 14, 2019

Package DI Number

20194717103018

Quantity per Package

1

Contains DI Package

10194717103011

Package Discontinue Date

June 18, 2021

Package Status

Not in Commercial Distribution

Package Type

-