Catalog Number

-

Brand Name

Regard™

Version/Model Number

GS00244C

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)

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

fe35b05e-28fb-4d3f-bca9-8219c1b82b1c

Public Version Date

November 11, 2019

Public Version Number

1

DI Record Publish Date

November 01, 2019

Package DI Number

20194717100086

Quantity per Package

2

Contains DI Package

10194717100089

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-