| Primary Device ID | 00816986020587 |
| NIH Device Record Key | 9ff55ed2-d45e-4eb6-9b17-83892423bc01 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StimTrial Stimulator Kit |
| Version Model Number | TS-5000 |
| Company DUNS | 078450878 |
| Company Name | BIOVENTUS LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 888-453-2136 |
| CustomerServiceUSA@bioventusglobal.com | |
| Phone | 888-453-2136 |
| CustomerServiceUSA@bioventusglobal.com | |
| Phone | 888-453-2136 |
| CustomerServiceUSA@bioventusglobal.com | |
| Phone | 888-453-2136 |
| CustomerServiceUSA@bioventusglobal.com | |
| Phone | 888-453-2136 |
| CustomerServiceUSA@bioventusglobal.com | |
| Phone | 888-453-2136 |
| CustomerServiceUSA@bioventusglobal.com | |
| Phone | 888-453-2136 |
| CustomerServiceUSA@bioventusglobal.com | |
| Phone | 888-453-2136 |
| CustomerServiceUSA@bioventusglobal.com | |
| Phone | 888-453-2136 |
| CustomerServiceUSA@bioventusglobal.com | |
| Phone | 888-453-2136 |
| CustomerServiceUSA@bioventusglobal.com | |
| Phone | 888-453-2136 |
| CustomerServiceUSA@bioventusglobal.com |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816986020587 [Primary] |
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-09 |
| Device Publish Date | 2025-09-01 |
| 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 |
| 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 | 2024-11-29 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 |