Duns Number:200564891
Device Description: (ADHESIVE) HYDROGEL SHEET with LEPTOSPERMUM HONEY
Catalog Number
DUP31740
Brand Name
MEDIHONEY® Hydrogel
Version/Model Number
31740
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
-
Product Code
FRO
Product Code Name
Dressing, wound, drug
Public Device Record Key
8349e55b-c8af-4215-84d1-9f0a3014b38f
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
October 23, 2018
Package DI Number
30381780471428
Quantity per Package
5
Contains DI Package
10381780471424
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 254 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |
| U | Unclassified | 42 |