Duns Number:657246112
Device Description: Hydration healing for wounds1. absorbing exudate (reduce the number of dressing changes, t Hydration healing for wounds1. absorbing exudate (reduce the number of dressing changes, to avoid interference with wound healing)2. Non-adherent and Non-linting (Easy to remove, won’t cause wound trama)3. Perfect conformity (Conform to wound’s figure perfectly, patients feel comfortable in their daily movements)
Catalog Number
HW2106
Brand Name
H&H
Version/Model Number
HW2106
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
NAE
Product Code Name
Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Public Device Record Key
21d12e80-63f4-4d81-90aa-84ce2b2ef265
Public Version Date
June 22, 2020
Public Version Number
1
DI Record Publish Date
June 12, 2020
Package DI Number
04719859641932
Quantity per Package
6
Contains DI Package
04719859641901
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 |