Duns Number:119193803
Device Description: Decrease waste and reduce your overall cost with MIXPAC T-Mixer HP Mixing Tips! New techno Decrease waste and reduce your overall cost with MIXPAC T-Mixer HP Mixing Tips! New technology provides a high mixing quality achieving more homogenous results. 100% compatible with original MIXPAC products. Tips available with color-trademarked domes consistent with the domes on standard MIXPAC mixing tips. Fits 4:1 or 10:1 cartridges.
Catalog Number
70-75294
Brand Name
MIXPAC T-Mixer Blue/Orange Mixing Tips
Version/Model Number
7075294
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EID
Product Code Name
Syringe, Restorative And Impression Material
Public Device Record Key
55535eca-4b75-42d0-a54a-c79ee7d3ae93
Public Version Date
August 30, 2018
Public Version Number
1
DI Record Publish Date
July 30, 2018
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 | 93 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |