Catalog Number

881003

Brand Name

Burnshield

Version/Model Number

881003

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

Product Code

MGQ

Product Code Name

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

Public Device Record Key

266c0172-614d-44f9-8772-76f745f1615c

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

June 12, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-