Duns Number:080240553
Device Description: The HemCon Dental Dressing PRO is a chitosan-based oral wound dressing intended as a physi The HemCon Dental Dressing PRO is a chitosan-based oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.
Catalog Number
1050
Brand Name
HemCon® Dental Dressing PRO, 10mm x 12mm
Version/Model Number
1
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K060363,K060363,K060363
Product Code
MGQ
Product Code Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Public Device Record Key
4c0e9ea7-3819-49ca-a160-12ae2648cba5
Public Version Date
July 19, 2021
Public Version Number
1
DI Record Publish Date
July 09, 2021
Package DI Number
20870053001033
Quantity per Package
12
Contains DI Package
00870053001039
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| U | Unclassified | 6 |