| Primary Device ID | D801SP514011 |
| NIH Device Record Key | 706f1f80-a92b-4d6f-975c-178968df656a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SciPharm NeoZoe, Temporary Cement |
| Version Model Number | SP 51-401 |
| Catalog Number | 51-401 |
| Company DUNS | 096010525 |
| Company Name | SCIENTIFIC PHARMACEUTICALS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 800-634-3047 |
| Denise@scipharm.com | |
| Phone | 800-634-3047 |
| Denise@scipharm.com |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D801SP514011 [Primary] |
| EMB | Zinc Oxide Eugenol |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-03 |
| D801SP514011 | NeoZoe - A Novel Form of Zinc Oxide / Eugenol Temporary Cement in Automix Dispensing System. 5 |
| D801SP51401 | NeoZoe - A Novel Form of Zinc Oxide / Eugenol Temporary Cement in Automix Dispensing System. 5 |