| Primary Device ID | M263W25000 |
| NIH Device Record Key | aefa5691-8f21-4b50-8658-0280ec304069 |
| Commercial Distribution Discontinuation | 2019-09-30 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | WizardBio Resorbable Calcium Phosphate Cement |
| Version Model Number | 21004-05 |
| Catalog Number | W25000 |
| Company DUNS | 131107757 |
| Company Name | DSM BIOMEDICAL, 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 | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M263W25000 [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 | 4 |
| Public Version Date | 2023-06-20 |
| Device Publish Date | 2019-01-02 |
| M263W23000 | WizardBio Resorbable Calcium Phosphate Cement |
| M263W21000 | WizardBio Resorbable Calcium Phosphate Cement |
| M263W25000 | WizardBio Resorbable Calcium Phosphate Cement |