Primary Device ID | D914SG500S0 |
NIH Device Record Key | 43cee096-cf45-40f6-964c-f0ad99f4f93d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SCIOGRAFT |
Version Model Number | SG-500-S |
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 | false |
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 | D914SG500S0 [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 |