Duns Number:929236305
Device Description: Microbrush Disposable Micro-Applicators, World English, M8 Fine 1.5mm, Yellow
Catalog Number
WMFY100
Brand Name
Microbrush
Version/Model Number
WMFY100
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
de589068-bda4-41fb-9f2b-2c360962649f
Public Version Date
October 05, 2022
Public Version Number
6
DI Record Publish Date
December 08, 2020
Package DI Number
10789594000463
Quantity per Package
100
Contains DI Package
00789594000466
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bottle
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 43 |