Duns Number:594970245
Catalog Number
-
Brand Name
ManukaPli 44ge
Version/Model Number
MM0051
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)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K092689
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
ae4c5e0a-6a88-4918-9a11-1cda39b98805
Public Version Date
May 14, 2020
Public Version Number
2
DI Record Publish Date
May 24, 2019
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 |