| Primary Device ID | 05391527770046 |
| NIH Device Record Key | 97632cad-731a-48db-905c-929c6e6aadb1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ReActiv8 IPG |
| Version Model Number | 7M5100-005 |
| Catalog Number | 5100 |
| Company DUNS | 985519015 |
| Company Name | MAINSTAY MEDICAL LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 |
| Phone | 877-702-8488 |
| info@mainstay-medical.com | |
| Phone | 877-702-8488 |
| info@mainstay-medical.com | |
| Phone | 877-702-8488 |
| info@mainstay-medical.com | |
| Phone | 877-702-8488 |
| info@mainstay-medical.com | |
| Phone | 877-702-8488 |
| info@mainstay-medical.com | |
| Phone | 877-702-8488 |
| info@mainstay-medical.com | |
| Phone | 877-702-8488 |
| info@mainstay-medical.com | |
| Phone | 877-702-8488 |
| info@mainstay-medical.com | |
| Phone | 877-702-8488 |
| info@mainstay-medical.com | |
| Phone | 877-702-8488 |
| info@mainstay-medical.com | |
| Phone | 877-702-8488 |
| info@mainstay-medical.com | |
| Phone | 877-702-8488 |
| info@mainstay-medical.com | |
| Phone | 877-702-8488 |
| info@mainstay-medical.com | |
| Phone | 877-702-8488 |
| info@mainstay-medical.com | |
| Phone | 877-702-8488 |
| info@mainstay-medical.com | |
| Phone | 877-702-8488 |
| info@mainstay-medical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05391527770046 [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 | 2025-02-21 |
| Device Publish Date | 2025-02-13 |
| 05391527770015 | ReActiv8 Implantable Pulse Generator |
| 05391527770046 | ReActiv8 Implantable Pulse Generator |