Duns Number:096191093
Device Description: Disposable Micro Applicators Super Fine White 400/bx. - MARK3®
Catalog Number
8098
Brand Name
MARK3
Version/Model Number
8098
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EJB
Product Code Name
Handle, Instrument, Dental
Public Device Record Key
58aab269-493d-4dbc-bbca-8168fb15edb8
Public Version Date
June 29, 2022
Public Version Number
1
DI Record Publish Date
June 21, 2022
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 96 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 93 |
| U | Unclassified | 1 |