Duns Number:079508934
Catalog Number
-
Brand Name
Dermapose Refresh
Version/Model Number
REFRESH
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
-
Product Code
MUU
Product Code Name
System, Suction, Lipoplasty
Public Device Record Key
3e5cdcf5-8679-4a11-8790-d6b814b0c77d
Public Version Date
November 22, 2021
Public Version Number
2
DI Record Publish Date
August 24, 2020
Package DI Number
10863445000359
Quantity per Package
24
Contains DI Package
00863445000352
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 | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 6 |