Duns Number:200564891
Device Description: Dressing with Active Leptospermum Honey
Catalog Number
31535
Brand Name
MediHoney®
Version/Model Number
31535
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
K080315,K080315
Product Code
FRO
Product Code Name
Dressing, wound, drug
Public Device Record Key
431a08ff-5d90-4914-9382-801e308e8322
Public Version Date
October 26, 2022
Public Version Number
3
DI Record Publish Date
August 28, 2018
Package DI Number
30381780486835
Quantity per Package
12
Contains DI Package
10381780486831
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 |