Duns Number:969752364
Device Description: Cosmetic Applicator Kit with GF (1 CA/pkg) - Includes a sterile, disposable cartridge tip, Cosmetic Applicator Kit with GF (1 CA/pkg) - Includes a sterile, disposable cartridge tip, MicroGlide GF, and a disposable sleeve.
Catalog Number
MP1002-CA-K1GF
Brand Name
Eclipse Cosmetic Applicator Kit
Version/Model Number
MP1002-CA-K1GF
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 03, 2019
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
-
Product Code Name
-
Public Device Record Key
f9363c71-f7eb-42a8-a6d8-3c3043df48cd
Public Version Date
July 07, 2020
Public Version Number
3
DI Record Publish Date
October 04, 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. | 14 |