Duns Number:200564891
Device Description: Calcium Alginate Dressing with Active Leptospermum Honey
Catalog Number
31012
Brand Name
MediHoney®
Version/Model Number
31012
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"
-
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
K053095,K053095
Product Code
FRO
Product Code Name
Dressing, wound, drug
Public Device Record Key
debe9271-dd26-4101-ac49-a3f4909831a9
Public Version Date
October 25, 2022
Public Version Number
4
DI Record Publish Date
March 06, 2019
Package DI Number
30381780486903
Quantity per Package
4
Contains DI Package
10381780486909
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 |