| Primary Device ID | 08809763501029 |
| NIH Device Record Key | f35834c9-d55d-4ddc-8568-32bcb2967bdd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MEGA SPINE SYSTEM |
| Version Model Number | 61650-60 |
| Company DUNS | 687941818 |
| Company Name | BK MEDITECH CO.,LTD. |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809763501029 [Primary] |
| HXC | Wrench |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08809763501029]
Moist Heat or Steam Sterilization
[08809763501029]
Moist Heat or Steam Sterilization
[08809763501029]
Moist Heat or Steam Sterilization
[08809763501029]
Moist Heat or Steam Sterilization
[08809763501029]
Moist Heat or Steam Sterilization
[08809763501029]
Moist Heat or Steam Sterilization
[08809763501029]
Moist Heat or Steam Sterilization
[08809763501029]
Moist Heat or Steam Sterilization
[08809763501029]
Moist Heat or Steam Sterilization
[08809763501029]
Moist Heat or Steam Sterilization
[08809763501029]
Moist Heat or Steam Sterilization
[08809763501029]
Moist Heat or Steam Sterilization
[08809763501029]
Moist Heat or Steam Sterilization
[08809763501029]
Moist Heat or Steam Sterilization
[08809763501029]
Moist Heat or Steam Sterilization
[08809763501029]
Moist Heat or Steam Sterilization
[08809763501029]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-03 |
| Device Publish Date | 2023-06-23 |
| 08809763500282 | Anti-Torque Driver |
| 08809763500251 | T-Wrench 3.0mm |
| 08809763500244 | T-Wrench 5.0mm (Short) |
| 08809763500237 | T-Wrench 5.0mm (Long) |
| 08809763500220 | Multi Screw Driver |
| 08809763500213 | Long arm Screw Driver |
| 08809763500206 | Mono Screw Driver |
| 08809763500183 | Rod Introducer |
| 08809763500114 | Guide Pin |
| 08809763500107 | Guide Pin |
| 08809763501890 | Locking Bolt Sleeve |
| 08809763501586 | Torque Limiting Wrench 3.0mm |
| 08809763501456 | Anti-Torque |
| 08809763501432 | Reducer |
| 08809763501388 | GR Reducer |
| 08809763501357 | SC Reducer |
| 08809763501319 | Multi-Axial Screw Driver |
| 08809763501302 | Long-Arm Screw Driver |
| 08809763501296 | Mono Screw Driver |
| 08809763501050 | Rod Reducer |
| 08809763501043 | Anti-Torque Driver |
| 08809763501029 | Pick-Up Wrench |
| 08809763501012 | Multi Screw Driver |
| 08809763501005 | Long-Arm Screw Driver |
| 08809763500992 | Mono Screw Driver |
| 08809763500985 | Long-Arm Breaker |
| 08809763500978 | Distractor |
| 08809763500961 | Compressor |
| 08809763500947 | Awl |
| 08809763500923 | Long-Arm Breaker |
| 08809763500916 | Derotator |
| 08809763500909 | Long-Arm Reduction Introducer |
| 08809763500787 | Final Wrench(5mm) |
| 08809763500756 | Multi Screw Driver |
| 08809763500749 | Long-Arm Screw Driver |
| 08809763500732 | Mono Screw Driver |
| 08809763500718 | Bent Probe |
| 08809763500701 | Straight Probe |
| 08809763500695 | Awl |
| 08809763500664 | T-Wrench 3.0mm |
| 08809763500657 | Final Wrench(5mm) |
| 08809763500640 | Pick-Up Wrench |
| 08809763500572 | Multi Screw Driver |
| 08809763500565 | Long-Arm Screw Driver |
| 08809763500558 | Mono Screw Driver |
| 08809763500534 | French Rod Bender |
| 08809763500527 | Rod Rocker |
| 08809763500510 | Reduction Introducer |
| 08809763500503 | Alignment Driver |
| 08809763500411 | Rod Pusher |