Duns Number:594970245
Device Description: A unit carton of six 3" x4" Manuka Honey coated adhesive island wound dressings
Catalog Number
-
Brand Name
ManukaMed Adhesive Dressings
Version/Model Number
MM0161
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K102659
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
bd6ba17c-7fde-4fb6-905b-de8e4e94bc39
Public Version Date
May 22, 2020
Public Version Number
1
DI Record Publish Date
May 14, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| U | Unclassified | 15 |