| Primary Device ID | 00813250017588 |
| NIH Device Record Key | f3a857c1-a32e-426a-965a-0e575099eb78 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | GTRT-16-76 |
| 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 | true |
| 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 Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813250017588 [Primary] |
| GXD | GENERATOR, LESION, RADIOFREQUENCY |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-10-08 |
| Device Publish Date | 2017-08-21 |
| 08714729888734 - Precision™ | 2024-09-24 M8 Adapter, 15cm |
| 08714729888758 - Precision™ | 2024-09-24 M8 Adapter, 55cm |
| 08714729893271 - Precision™ | 2024-09-24 S8 Adapter, 15cm |
| 08714729893288 - Precision™ | 2024-09-24 S8 Adapter, 55cm |
| 08714729897804 - NA | 2024-08-21 Installer for BN3.1 |
| 08714729897811 - NA | 2024-08-21 Clinician Programmer |
| 08714729897835 - Precision Novi™ | 2024-08-21 Implantable Pulse Generator Kit |
| 08714729897873 - NA | 2024-08-21 Clinican Programmer (Refurbished) |