Duns Number:062312574
Device Description: Manuka Honey Spot Bandages Infused with Natural Medical-Grade Honey
Catalog Number
405427
Brand Name
CVS Health™
Version/Model Number
405427
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
K081584,K081584
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
2026a810-4051-44af-a456-619b2ad714fa
Public Version Date
October 03, 2022
Public Version Number
1
DI Record Publish Date
September 24, 2022
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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139 |
| U | Unclassified | 23 |