| Primary Device ID | D914SG100L0 |
| NIH Device Record Key | 3a83afa0-e76b-4982-8a0c-bd37287b5796 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SCIOGRAFT |
| Version Model Number | SG-100-L |
| Company DUNS | 972044937 |
| Company Name | ODONTIT S.A. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D914SG100L0 [Primary] |
| NPM | Bone Grafting Material, Animal Source |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-06 |
| Device Publish Date | 2024-02-27 |
| D914SG500S0 | SCIOGRAFT 5,00 CC BOVINE BONE GRAFT 350-840 MICRON VIAL |
| D914SG500L0 | SCIOGRAFT 5,00 CC BOVINE BONE GRAFT 840-2000 MICRON VIAL |
| D914SG250S0 | SCIOGRAFT 2,50 CC BOVINE BONE GRAFT 350-840 MICRON VIAL |
| D914SG250L0 | SCIOGRAFT 2,50 CC BOVINE BONE GRAFT 840-2000 MICRON VIAL |
| D914SG100S0 | SCIOGRAFT 1,0 CC BOVINE BONE GRAFT 350-840 MICRON VIAL |
| D914SG100L0 | SCIOGRAFT 1,0 CC BOVINE BONE GRAFT 840-2000 MICRON VIAL |
| D914SG050S0 | SCIOGRAFT 0,5 CC BOVINE BONE GRAFT 350-840 MICRON VIAL |
| D914SG050L0 | SCIOGRAFT 0,5 CC BOVINE BONE GRAFT 840-2000 MICRON VIAL |
| D914SG025S0 | SCIOGRAFT 0,25 CC BOVINE BONE GRAFT 350-840 MICRON VIAL |
| D914SG025L0 | SCIOGRAFT 0,25 CC BOVINE BONE GRAFT 840-2000 MICRON VIAL |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SCIOGRAFT 97541764 not registered Live/Pending |
Intra-Lock Dental Inc. 2022-08-09 |