Duns Number:320744915
Device Description: Automix-Tips Green 1:1. Suitable for Honigum Pro-Mono, Honigum Pro-Heavy, Honigum Pro-Heav Automix-Tips Green 1:1. Suitable for Honigum Pro-Mono, Honigum Pro-Heavy, Honigum Pro-Heavy Scan, Honigum Mono, Honigum Heavy. Content: 50 tips.
Catalog Number
999400
Brand Name
Automix-Tips Green 1:1
Version/Model Number
999400
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
EID
Product Code Name
Syringe, Restorative And Impression Material
Public Device Record Key
89437dc0-2864-40be-aabd-f0cc146c52fe
Public Version Date
September 09, 2022
Public Version Number
1
DI Record Publish Date
September 01, 2022
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 | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 143 |