| Primary Device ID | 08809539699691 |
| NIH Device Record Key | 12acc065-8e85-4c17-8183-9cd1c4fb2a3b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Neuro Plating System |
| Version Model Number | TPN-005 |
| Company DUNS | 688999370 |
| Company Name | OSTEONIC 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 | true |
| 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 | 08809539699691 [Primary] |
| FSM | Tray, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
[08809539699691]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-06-04 |
| Device Publish Date | 2019-02-18 |
| 08809595972721 | 3D Mesh Plate(200*200mm/0.6t) |
| 08809595973049 | ALU Tray coated with PU (body + drawer + Lid) |
| 08809595973025 | Forceps |
| 08809595973018 | Hand Driver (Small) |
| 08809595973001 | Hand Driver (Big) |
| 08809595972998 | 1x Magazine + 1x Cover + 6x Rescue screws 6mm |
| 08809595972981 | 1x Magazine + 1x Cover + 6x Rescue screws 4mm |
| 08809595972974 | 1x Magazine + 1x Cover + 6x Screws 5mm |
| 08809595972967 | 1x Magazine + 1x Cover + 6x Screws 3mm |
| 08809595972950 | 1x Screw disk + 100 screws 4mm |
| 08809595972820 | 10x Rescue screws 6mm |
| 08809595972806 | 10x Rescue screws 4mm |
| 08809595972783 | 10 x screws 5mm |
| 08809595972769 | 10 x screws 3mm |
| 08809595972745 | 10 x screws 4mm |
| 08809595972714 | 3D Mesh Plate(150*150mm/0.6t) |
| 08809595972707 | 3D Mesh Plate(50*50mm/0.6t) |
| 08809595972691 | Temporal Mesh Plate (42.2*25.1mm/0.4t) |
| 08809539699820 | IOC-141 |
| 08809539699691 | ALU Tray oxidized (body + drawer + lid) |
| 08809416061917 | Burr Hole Calvarium Plate, Long, 6Hole |
| 08809416061900 | Burr Hole Calvarium Plate, Middle, 6Hole |
| 08809416061887 | Burr Hole Plate Slot, Extra, 5Hole |
| 08809416061870 | Burr Hole Plate Slot, Long, 5Hole |
| 08809416061863 | Burr Hole Plate Slot, Middle, 5Hole |
| 08809416061856 | Burr Hole Plate Slot, Short, 5Hole |
| 08809416061849 | Burr Hole Plate, Extra, 6Hole |
| 08809416061832 | Burr Hole Plate, Long, 6Hole |
| 08809416061825 | Burr Hole Plate, Middle, 6Hole |
| 08809416061818 | Burr Hole Plate, Short, 6Hole |
| 08809416061801 | Gap Plate, Long, 6Hole |
| 08809416061795 | Gap Plate, Middle, 6Hole |
| 08809416061788 | Gap Plate, Short, 6Hole |
| 08809416061733 | Y-Plate, Middle, 5Hole |
| 08809416061726 | Matrix Plate, Long, 8Hole |
| 08809416061719 | Matrix Plate, Middle, 8Hole |
| 08809416061702 | Double Square Plate, Middle, 6Hole |
| 08809416061696 | Rectangular Plate, Middle, 4Hole |
| 08809416061689 | Square Plate, Extra Long, 4Hole |
| 08809416061672 | Square Plate, Long, 4Hole |
| 08809416061665 | Square Plate, Middle, 4Hole |
| 08809416061658 | X-Plate, Middle, 4Hole |
| 08809416061641 | D-Y Plate, Long, 6Hole |
| 08809416061634 | D-Y Plate, Middle, 6Hole |
| 08809416061627 | Straight Plate, Middle, 20Hole |
| 08809416061603 | Straight Plate, Middle, 10Hole |
| 08809416061580 | Straight Plate, Middle, 6Hole |
| 08809416061573 | Straight Plate, Middle, 5Hole |
| 08809416061566 | Straight Plate, Extra, 4Hole |
| 08809416061559 | Straight Plate, Middle, 4Hole |