Duns Number:005677967
Device Description: Case of 24 count of Single Treatment Kits - SkinPen Precision
Catalog Number
F5SP014
Brand Name
SkinPen
Version/Model Number
1
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
QAI
Product Code Name
Powered Microneedle Device
Public Device Record Key
359277da-d1df-43bb-bbf8-a931d65ce434
Public Version Date
May 10, 2022
Public Version Number
5
DI Record Publish Date
April 12, 2018
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 15 |