| Primary Device ID | 08714729989295 | 
| NIH Device Record Key | 9f4b092c-9cf4-409b-bfc6-c84e201e5878 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Version Model Number | DB-6358-5BK | 
| 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 | 08714729989295 [Primary] | 
| NHL | Stimulator, electrical, implanted, for parkinsonian symptoms | 
| PJS | Stimulator, electrical, implanted, for essential tremor | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2021-02-05 | 
| Device Publish Date | 2021-01-28 | 
| 00191506048464 - GX1™ | 2025-10-07 Radiofrequency Generator 2.0A, 120V | 
| 00191506048518 - GX1™ | 2025-10-07 Radiofrequency Generator 2.0A, 220V | 
| 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 |