| Primary Device ID | 00852108006411 |
| NIH Device Record Key | b1663e09-5467-4713-8931-5b89a2d7dcc7 |
| Commercial Distribution Discontinuation | 2019-12-12 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Callisto Granules Beta-TCP Synthetic Bone Graft |
| Version Model Number | 02-100-03-VEX |
| Catalog Number | VX-23310 |
| Company DUNS | 024222105 |
| Company Name | CYTOPHIL, INC. |
| 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 | 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 |
| Total Volume | 10 Milliliter |
| Storage Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852108006411 [Primary] |
| MQV | Filler, Bone Void, Calcium Compound |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-12-12 |
| Device Publish Date | 2019-10-30 |
| 00852108006411 | Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intend |
| 00852108006404 | Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intend |
| 00852108006381 | Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intend |
| 00852108006367 | Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intend |