Duns Number:657246112
Device Description: Effective treatment for scar1. Maintain proper moist environment2. Support and close the w Effective treatment for scar1. Maintain proper moist environment2. Support and close the wound3. Tissue well arrayed, reduce scar proliferation.
Catalog Number
SH2106
Brand Name
H&H
Version/Model Number
SH2106
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAD
Product Code Name
Dressing, Wound, Occlusive
Public Device Record Key
aa25502d-19c0-43db-890b-9382fae3f8c6
Public Version Date
June 22, 2020
Public Version Number
1
DI Record Publish Date
June 12, 2020
Package DI Number
04719859642007
Quantity per Package
6
Contains DI Package
04719859642052
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |