Duns Number:113170088
Device Description: A2 Tips are 15 gauge, light impervious tips designed to dispense flowable, light cure adhe A2 Tips are 15 gauge, light impervious tips designed to dispense flowable, light cure adhesives. Qty 5 per packacge
Catalog Number
A2TIP
Brand Name
A2 - Tips
Version/Model Number
A2TIP
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 01, 2016
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)
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
1b2ca016-fbae-43ae-847b-3922ff67a33d
Public Version Date
August 21, 2019
Public Version Number
6
DI Record Publish Date
July 18, 2016
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 | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 279 |