Catalog Number

550000

Brand Name

BURNSHIELD

Version/Model Number

550000

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

K943728,K943728,K943728

Product Code

MGQ

Product Code Name

Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Public Device Record Key

7ba7e284-c846-4658-b727-03d0ba125228

Public Version Date

August 30, 2021

Public Version Number

1

DI Record Publish Date

August 20, 2021

Package DI Number

16007645000120

Quantity per Package

6

Contains DI Package

06007645000123

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX