Duns Number:200564891
Device Description: Gel Dressing with Active Leptospermum Honey
Catalog Number
DUP31840
Brand Name
MEDIHONEY® Gel
Version/Model Number
31840
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K150985,K150985
Product Code
FRO
Product Code Name
Dressing, wound, drug
Public Device Record Key
8aab7a5c-4207-46e7-a1a6-9eee315ec5c5
Public Version Date
July 22, 2021
Public Version Number
2
DI Record Publish Date
March 07, 2019
Package DI Number
30381780486897
Quantity per Package
6
Contains DI Package
10381780486893
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 |