Catalog Number

550013F

Brand Name

BURNSHIELD

Version/Model Number

550013F

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

6eed9a20-2552-4556-826d-02d48cd8c4a0

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

November 11, 2020

Package DI Number

16007645006337

Quantity per Package

5

Contains DI Package

06007645006330

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX