| Primary Device ID | 05391527772279 |
| NIH Device Record Key | 19b21841-c4c3-43ff-b018-6418b4ab70a5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ReActiv8 Stimulation Lead |
| Version Model Number | 7M8165-006 |
| Catalog Number | 8165 |
| Company DUNS | 985519015 |
| Company Name | MAINSTAY MEDICAL LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| 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 | 05391527772279 [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 |
| 05391527772279 | Stimulation Lead, 65 cm length, Assembled, tray packed, and sterilized at Oscor Caribe, then fin |
| 05391527772262 | Stimulation Lead, 65 cm length, Assembled and tray packed at OC, then sterilized and final packa |
| 05391527772071 | Assembled, tray packed, and sterilized at Oscor Caribe, then final packaged at Oscor, Inc. |
| 05391527772064 | Stimulation Lead, 45 cm length, Assembled and tray packed at Oscor Caribe, then sterilized and f |