| Primary Device ID | 05391527772415 |
| NIH Device Record Key | 741be66b-4d63-4ecd-9a2a-0edf0d2ec6ef |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mainstay Tunneler |
| Version Model Number | 7MTUN1-002 |
| Catalog Number | TUN1 |
| Company DUNS | 985519015 |
| Company Name | MAINSTAY MEDICAL LIMITED |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 | 05391527772415 [Primary] |
| QLK | Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-02 |
| Device Publish Date | 2021-01-25 |
| 05391527772804 - ReActiv8 Release Tool | 2024-01-30 |
| 05391527770015 - ReActiv8 IPG | 2021-02-02 ReActiv8 Implantable Pulse Generator |
| 05391527770213 - ReActiv8 Programming Wand | 2021-02-02 Programming Wand |
| 05391527770411 - ReActiv8 Activator | 2021-02-02 ReActiv8 Activator (for patient use to initiate ReActiv8 Therapy Delivery) |
| 05391527770626 - ReActiv8 Magnet | 2021-02-02 ReActiv8 Magnet (for use in starting or stopping therapy dependent upon IPG programming). |
| 05391527770633 - ReActiv8 Magnet | 2021-02-02 ReActiv8 Magnet (for use in starting or stopping therapy dependent upon IPG programming). |
| 05391527770817 - ReActiv8 Torque Wrench | 2021-02-02 Torque Wrench (packaged as a standalone accessory) |
| 05391527772064 - ReActiv8 Stimulation Lead | 2021-02-02 Stimulation Lead, 45 cm length, Assembled and tray packed at Oscor Caribe, then sterilized and final packaged at Oscor, Inc. |