Catalog Number

550003

Brand Name

Burnshield

Version/Model Number

550003

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

Product Code

MGQ

Product Code Name

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

Public Device Record Key

08ef93ea-b31b-43b5-8507-14f25f1b6f1a

Public Version Date

August 24, 2021

Public Version Number

3

DI Record Publish Date

December 17, 2018

Package DI Number

36007645000193

Quantity per Package

48

Contains DI Package

06007645000192

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX