Duns Number:635842958
Device Description: BURNSHIELD HYDROGEL TUBE 10ML (0.35 OZ)
Catalog Number
550010
Brand Name
BURNSHIELD
Version/Model Number
550010
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
beb8dfea-8e04-4c62-9b18-e1fb5bb79fc2
Public Version Date
August 24, 2021
Public Version Number
2
DI Record Publish Date
July 25, 2020
Package DI Number
26007645004590
Quantity per Package
50
Contains DI Package
06007645004596
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
U | Unclassified | 19 |