| Primary Device ID | 10889981212025 |
| NIH Device Record Key | 86bdbb72-cc8c-48ad-a35a-484cf57fa9c0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mariner Outrigger |
| Version Model Number | 99-0025 |
| Catalog Number | 99-0025 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10889981212025 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10889981212025]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-04-06 |
| Device Publish Date | 2020-03-27 |
| 10889981213695 | Top Loading, Offset Caddy |
| 10889981212025 | Box Chisel, Angled |
| 10889981212018 | Box Chisel, Straight |
| 10889981212001 | C-Chisel, Angled |
| 10889981211998 | C-Chisel, Straight |
| 10889981184995 | Parallel, Closed, Variable 8mm |
| 10889981184988 | Parallel, Closed, Variable 8mm |
| 10889981255886 | Fixed Axial Handle, Large, Impacting, Radel Core |
| 10889981184889 | L-Con Caddy |
| 10889981184872 | Z-Rod Caddy |
| 10889981184865 | Gimbal Caddy |
| 10889981184858 | Side-Loading Caddy |
| 10889981184841 | Top Loading Caddy |
| 10889981184834 | Closed/Closed Caddy |
| 10889981184827 | Mariner Outrigger Implants |
| 10889981184810 | Mariner Outrigger Instruments |
| 10889981184803 | Mariner Outrigger Base |
| 10889981172473 | Fixed Axial Handle, Midium, Impacting, Radel Core |
| 10889981206390 | Counter Torque Handle |
| 10889981172350 | Rasp |