| Primary Device ID | 08714729996712 |
| NIH Device Record Key | e910d151-45ef-47af-99fa-ae0b5a52633e |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | SC-6386 |
| Company DUNS | 824951958 |
| Company Name | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08714729996712 [Primary] |
| LGW | Stimulator, spinal-cord, totally implanted for pain relief |
| QRB | Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-05 |
| Device Publish Date | 2020-12-28 |
| 08714729950684 - Entrada ™ | 2025-08-25 Needle 11cm (4.5in) |
| 08714729950691 - Entrada ™ | 2025-08-25 Needle 15cm (6.0 in) |
| 08714729950707 - Entrada ™ | 2025-08-25 Spare Sheath 11cm (4.5 in) |
| 08714729950714 - Entrada ™ | 2025-08-25 Spare Sheath 15cm (6.0 in) |
| 08714729952053 - Freelink™ | 2025-08-25 Remote Control |
| 08714729953449 - Freelink™ | 2025-08-25 Remote Control Kit |
| 08714729953487 - Bionic Navigator™ 3D | 2025-08-25 BN 3D 2.0 Installer |
| 08714729820758 - Vercise™ | 2025-08-12 Implantable Pulse Generator Kit |