| Primary Device ID | 00813250017229 |
| NIH Device Record Key | d5e7ebbf-2f1c-48e0-847c-860b3af2d41f |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | C103-RTM |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00813250017229 [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 |
| 00191506018726 - Infinion™ Pro | 2024-04-30 Lead Kit 16 Contact 50cm |
| 00191506018733 - Infinion™ Pro | 2024-04-30 Lead Kit 16 Contact 70cm |
| 00191506020583 - mySCS™ GO | 2024-04-30 Therapy Controller |
| 00191506020606 - mySCS™ GO | 2024-04-30 Therapy Controller |
| 00191506020705 - mySCS™ GO | 2024-04-30 Therapy Controller App |
| 08714729121688 - Precision ™ | 2024-03-25 Adhesive Kit |
| 08714729121435 - Precision™ | 2024-03-19 Hex Wrench |
| 08714729121442 - NA | 2024-03-19 10cm (4 Inch) Insertion Needle |