| Primary Device ID | 00816986020525 |
| NIH Device Record Key | d1009662-473f-44bb-b380-9fc817bb425d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Osteoamp Flowable Access Cannula |
| Version Model Number | OFAC-C |
| Catalog Number | OFAC-C |
| Company DUNS | 078450878 |
| Company Name | BIOVENTUS LLC |
| 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 |
| Phone | 800-637-4391 |
| CSSurgical@bioventusglobal.com | |
| Phone | 800-637-4391 |
| CSSurgical@bioventusglobal.com | |
| Phone | 800-637-4391 |
| CSSurgical@bioventusglobal.com | |
| Phone | 800-637-4391 |
| CSSurgical@bioventusglobal.com | |
| Phone | 800-637-4391 |
| CSSurgical@bioventusglobal.com | |
| Phone | 800-637-4391 |
| CSSurgical@bioventusglobal.com | |
| Phone | 800-637-4391 |
| CSSurgical@bioventusglobal.com | |
| Phone | 800-637-4391 |
| CSSurgical@bioventusglobal.com | |
| Phone | 800-637-4391 |
| CSSurgical@bioventusglobal.com | |
| Phone | 800-637-4391 |
| CSSurgical@bioventusglobal.com |
| Storage Environment Temperature | Between 11 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816986020525 [Primary] |
| FMF | Syringe, Piston |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-29 |
| Device Publish Date | 2024-11-21 |
| 00816986020549 - TalisMann Implant Kit | 2025-09-09 |
| 00816986020556 - StimTrial Surgical Kit | 2025-09-09 |
| 00816986020570 - StimTrial Patient Kit | 2025-09-09 |
| 00816986020587 - StimTrial Stimulator Kit | 2025-09-09 |
| 00816986020617 - Bioventus User Kit | 2025-09-09 |
| 00816986020624 - Bioventus Clinician Kit | 2025-09-09 |
| 00816986020525 - Osteoamp Flowable Access Cannula | 2024-11-29The Allograft Delivery Device consists of a cannula and push rod made of biocompatible polypropylene. The device is provided sterile and is intended to be used with hydrated allograft to facilitate delivery into bony defects in orthopedic surgical sites. |
| 00816986020525 - Osteoamp Flowable Access Cannula | 2024-11-29 The Allograft Delivery Device consists of a cannula and push rod made of biocompatible polypropylene. The device is provided ste |
| 10389130444418 - SUPARTZ FX sodium hyaluronate | 2023-10-06 SUPARTZ FX (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respon |