Catalog Number

881010

Brand Name

Burnshield

Version/Model Number

881010

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

2ec03b41-1b78-4ef4-bfa8-c1ae5fa9d2c2

Public Version Date

August 24, 2021

Public Version Number

3

DI Record Publish Date

November 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-