| Primary Device ID | M958BSF00075 |
| NIH Device Record Key | 92d82eda-3be1-4b09-81fa-e6ab584d5fb7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioSphere Flex SP |
| Version Model Number | Medium |
| Catalog Number | BSF-00075 |
| Company DUNS | 078270195 |
| Company Name | SYNERGY BIOMEDICAL, 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 | 484-902-8141 |
| info@synergybiomedical.com |
| Total Volume | 7.5 Milliliter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M958BSF00075 [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 | 2020-02-10 |
| Device Publish Date | 2020-01-31 |
| M958BMS250KT0 - BioSphere MIS Kit | 2024-12-17 |
| M958BMS250RC0 - BioSphere MIS Replacement Cannula | 2024-12-17 |
| M958BSF000300 - BioSphere Flex SP Extremities, Small | 2021-06-09 BioSphere Flex SP Extremities, Small |
| M958BSF000400 - BioSphere Flex SP Extremities, Medium | 2021-06-09 BioSphere Flex SP Extremities, Medium |
| M958BSF250500 - BioSphere Flex, Medium | 2021-06-09 BioSphere Flex, Medium |
| M958BSF251000 - BioSphere Flex, Large | 2021-06-09 BioSphere Flex, Large |
| M958BSF00075 - BioSphere Flex SP | 2020-02-10 |
| M958BSF00075 - BioSphere Flex SP | 2020-02-10 |