| Primary Device ID | 10889981300036 |
| NIH Device Record Key | bbb7fa30-dfff-42e0-a364-d561e12cee55 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mariner RDX MIS |
| Version Model Number | MX2-001020 |
| Catalog Number | MX2-001020 |
| Company DUNS | 079840876 |
| Company Name | SEASPINE ORTHOPEDICS CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| 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 |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10889981300036 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10889981300036]
Moist Heat or Steam Sterilization
[10889981300036]
Moist Heat or Steam Sterilization
[10889981300036]
Moist Heat or Steam Sterilization
[10889981300036]
Moist Heat or Steam Sterilization
[10889981300036]
Moist Heat or Steam Sterilization
[10889981300036]
Moist Heat or Steam Sterilization
[10889981300036]
Moist Heat or Steam Sterilization
[10889981300036]
Moist Heat or Steam Sterilization
[10889981300036]
Moist Heat or Steam Sterilization
[10889981300036]
Moist Heat or Steam Sterilization
[10889981300036]
Moist Heat or Steam Sterilization
[10889981300036]
Moist Heat or Steam Sterilization
[10889981300036]
Moist Heat or Steam Sterilization
[10889981300036]
Moist Heat or Steam Sterilization
[10889981300036]
Moist Heat or Steam Sterilization
[10889981300036]
Moist Heat or Steam Sterilization
[10889981300036]
Moist Heat or Steam Sterilization
[10889981300036]
Moist Heat or Steam Sterilization
[10889981300036]
Moist Heat or Steam Sterilization
[10889981300036]
Moist Heat or Steam Sterilization
[10889981300036]
Moist Heat or Steam Sterilization
[10889981300036]
Moist Heat or Steam Sterilization
[10889981300036]
Moist Heat or Steam Sterilization
[10889981300036]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-03 |
| Device Publish Date | 2023-03-24 |
| 10889981300043 | Mariner RDX MIS Stylet |
| 10889981300036 | Mariner RDX MIS Counter Torque Handle |
| 10889981298654 | Mariner RDX MIS Counter Torque |
| 10889981298647 | Mariner RDX MIS Polyaxial Head |