Catalog Number

550013

Brand Name

BURNSHIELD

Version/Model Number

550013

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,K943728

Product Code

MGQ

Product Code Name

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

Public Device Record Key

3fc6b08d-eec6-4fd1-8558-db64e516f741

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

July 25, 2020

Package DI Number

36007645001541

Quantity per Package

100

Contains DI Package

06007645001540

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX