Duns Number:102422578
Device Description: Single-use leur-lock dental applicator brush.
Catalog Number
-
Brand Name
Visco Tip
Version/Model Number
01808
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
-
Product Code
KXR
Product Code Name
Applicator, Resin
Public Device Record Key
d2217986-5953-4b34-8fce-6572439a5656
Public Version Date
November 08, 2018
Public Version Number
2
DI Record Publish Date
September 21, 2018
Package DI Number
00872320000479
Quantity per Package
50
Contains DI Package
00872320004392
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 51 |