| Primary Device ID | 08714729978404 |
| NIH Device Record Key | 398ff16d-7e76-4f60-9cd0-6bad53e7eaca |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spectra WaveWriter™ |
| Version Model Number | SC-5160R |
| 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 | true |
| 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 | 08714729978404 [Primary] |
| LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2025-09-30 |
| Device Publish Date | 2018-05-11 |
| 08714729978404 | External Trial Stimulator (Refurbished) |
| 08714729953432 | Implantable Pulse Generator and Charging Kit |
| 08714729952046 | External Trial Stimulator |
| 08714729951254 | Implantable Pulse Generator Kit |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SPECTRA WAVEWRITER 86910691 not registered Live/Pending |
Boston Scientific Neuromodulation Corporation 2016-02-17 |