Duns Number:199354556
Device Description: Mixing Tips Refill; Intended for use with intraoral and root-canal tips to dispense Maxcem Mixing Tips Refill; Intended for use with intraoral and root-canal tips to dispense Maxcem Elite
Catalog Number
33879
Brand Name
Mixing Tips
Version/Model Number
33879
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
EID
Product Code Name
SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL
Public Device Record Key
520d1c1a-b4cf-47da-b185-92dff1258e5d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 12, 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 | 98 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 595 |
| U | Unclassified | 5 |