| Primary Device ID | 00817771027385 |
| NIH Device Record Key | b60d9604-2e91-49da-8c9a-2d189a7a86ca |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SpineSmith Fusionary Graft Delivery System |
| Version Model Number | 0852-0001 |
| Catalog Number | 0852-0001 |
| Company DUNS | 021560394 |
| Company Name | Celling Biosciences |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
|---|---|
| GS1 | 00817771027385 [Primary] |
| FMF | Syringe, Piston |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-12-29 |
| 00817771027613 | ART GFC Kit |
| 00817771027408 | Celling Injection Kit |
| 00817771027392 | 120cc: Graft Delivery Kit |
| 00817771027385 | Graft Delivery Kit |
| 00817771027378 | Blood Draw Kit |
| 00817771027361 | Small Volume Bone Marrow Aspiration Kit |
| 00817771027354 | Bone Marrow Aspiration Kit |
| 00817771027347 | BMA Kit Large Volume |
| 00817771027330 | BMA Kit Classic |
| 00817771027323 | BMA Kit Standard |
| 00817771027316 | BMA Kit with 30cc Syringes |