Duns Number:929236305
Device Description: Microbrush M10 Sion Dispenser with Ultrabrush Bristle Brush Short Neck Applicators, 200 St Microbrush M10 Sion Dispenser with Ultrabrush Bristle Brush Short Neck Applicators, 200 Strand, Regular 2.0mm, Green
Catalog Number
U2D
Brand Name
Ultrabrush
Version/Model Number
U2D
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KXR
Product Code Name
APPLICATOR, RESIN
Public Device Record Key
ae411abd-8abc-4de3-9ba0-90d8dbc436b1
Public Version Date
October 05, 2022
Public Version Number
6
DI Record Publish Date
December 08, 2020
Package DI Number
10789594000722
Quantity per Package
100
Contains DI Package
00789594000725
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Package
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 43 |