Duns Number:096010525
Device Description: NeoZoe - A Novel Form of Zinc Oxide / Eugenol Temporary Cement in Automix Dispensing Syste NeoZoe - A Novel Form of Zinc Oxide / Eugenol Temporary Cement in Automix Dispensing System. 5 mL. Dual Barrel Syringe. Labeled
Catalog Number
51-401
Brand Name
SciPharm NeoZoe, Temporary Cement
Version/Model Number
SP 51-401
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
EMB
Product Code Name
Zinc Oxide Eugenol
Public Device Record Key
706f1f80-a92b-4d6f-975c-178968df656a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 03, 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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 476 |