Duns Number:199354556
Device Description: Nexus Universal Syringes(s): Clear with Chroma, Nexus Universal Clear, Nexus Universal Wh Nexus Universal Syringes(s): Clear with Chroma, Nexus Universal Clear, Nexus Universal White, Nexus Universal Yellow, Automix Tips and Optibond Universal bottle w/mixing well.
Catalog Number
36989
Brand Name
Nexus Universal Intro Kit
Version/Model Number
36989
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
-
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
EMA
Product Code Name
Cement, Dental
Public Device Record Key
9c8e1e25-922f-4e24-ac4e-196a090a74ff
Public Version Date
June 22, 2020
Public Version Number
1
DI Record Publish Date
June 12, 2020
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 |