| Primary Device ID | 00812337020435 |
| NIH Device Record Key | de8ad084-89d2-4714-ab07-a2fe84255612 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BoneSync Fast-Setting Drillable Calcium Phosphate Cement, 1cc |
| Version Model Number | 21003-04 |
| Catalog Number | ABS-3101 |
| 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 | 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 |
|---|---|
| GS1 | 00812337020435 [Primary] |
| MQV | Filler, Bone Void, Calcium Compound |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-17 |
| Device Publish Date | 2023-05-09 |
| 00812337020541 - Resolve Matrix™ Biologic Membrane | 2023-12-26 Resolve Matrix™ 2 cm x 2 cm |
| 00812337020558 - Resolve Matrix™ Biologic Membrane | 2023-12-26 Resolve Matrix™ 2 cm x 4 cm |
| 00812337020565 - Resolve Matrix™ Biologic Membrane | 2023-12-26 Resolve Matrix™ 4 cm x 5 cm |
| 00812337020572 - Resolve Matrix™ Biologic Membrane | 2023-12-26 Resolve Matrix™ 6 cm x 8 cm |
| 00812337020589 - Resolve Matrix™ Biologic Membrane | 2023-12-26 Resolve Matrix™ 2 cm x 3 cm |
| 00812337020596 - Resolve Matrix™ Biologic Membrane | 2023-12-26 Resolve Matrix™ 3 cm x 4 cm |
| 00812337020602 - xenoPATCH™ | 2023-12-20 |
| M263W25000 - WizardBio Resorbable Calcium Phosphate Cement | 2023-06-20 WizardBio Resorbable Calcium Phosphate Cement |