| 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 |
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| 00191506048563 - GX1™ | 2025-10-07 Radiofrequency Generator 2.0A, 240V |
| 00191506059309 - GX1™ | 2025-10-07 Radiofrequency Generator |
| 00191506059330 - GX1™ | 2025-10-07 GX1 RF GENERATOR HW 120V |
| 00191506059347 - GX1™ | 2025-10-07 GX1 RF GENERATOR HW 220V |
| 00191506059354 - GX1™ | 2025-10-07 GX1 RF GENERATOR HW 240V |
| 08714729951254 - Spectra WaveWriter™ | 2025-09-30 Implantable Pulse Generator Kit |