Duns Number:969752364
Device Description: MicroPen EVO Turbo Safety Cartridge (Each). Cartridges are sterilized and packaged individ MicroPen EVO Turbo Safety Cartridge (Each). Cartridges are sterilized and packaged individually for single patient use.
Catalog Number
50EVO2000-010
Brand Name
Eclipse EVO Microneedling Cartridge
Version/Model Number
50EVO2000-010
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
K203144,K212558,K203144,K212558
Product Code
QAI
Product Code Name
Powered Microneedle Device
Public Device Record Key
901ac6ee-621c-4faf-9505-09578b9e5180
Public Version Date
January 19, 2022
Public Version Number
1
DI Record Publish Date
January 11, 2022
Package DI Number
10853602008397
Quantity per Package
12
Contains DI Package
00853602008390
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |