| Primary Device ID | 00817867020740 |
| NIH Device Record Key | 0f7534e4-29b8-408c-b2ee-8d92f72ba957 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Drive Rail System |
| Version Model Number | 29-0012 |
| Catalog Number | 29-0012 |
| Company DUNS | 796416191 |
| Company Name | ORTHOPEDIATRICS CORP. |
| 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(574)268-6379 |
| yli@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| yli@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| yli@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| yli@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| yli@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| yli@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| yli@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| yli@orthopediatrics.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817867020740 [Primary] |
| HXC | WRENCH |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00817867020740]
Moist Heat or Steam Sterilization
[00817867020740]
Moist Heat or Steam Sterilization
[00817867020740]
Moist Heat or Steam Sterilization
[00817867020740]
Moist Heat or Steam Sterilization
[00817867020740]
Moist Heat or Steam Sterilization
[00817867020740]
Moist Heat or Steam Sterilization
[00817867020740]
Moist Heat or Steam Sterilization
[00817867020740]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-27 |
| Device Publish Date | 2022-06-17 |
| 00840194411219 | 10mm Driver, Square Drive |
| 00840194411158 | Allen Wrench 3/16" |
| 00817867021006 | Hinge and Arch Tray |
| 00817867020993 | Hinge and Arch Screw Caddy |
| 00817867020887 | 3 mm 90° HEX WRENCH |
| 00817867020856 | Rail and Clamp Screw Caddy |
| 00817867020849 | Rail and Clamp Tray |
| 00817867020832 | Lid |
| 00817867020825 | 10 mm AND 13 mm OPEN END WRENCH |
| 00817867020801 | RAIL ASSEMBLY TOOL |
| 00817867020795 | 10 mm Ratchet Wrench |
| 00817867020788 | 3/16" HEX DRIVER |
| 00817867020771 | TORQUE T-HANDLE |
| 00817867020764 | 10 mm BOLT DRIVER |
| 00817867020740 | 10 mm COMBINATION WRENCH |
| 00817867020733 | 3/16" L-HEX DRIVER |
| 00817867020672 | SET SCREW |
| 00817867020665 | SCREW, CLAMP TO CARRIAGE |
| 00817867020658 | SCREW, SHORT, CLAMP TO CARRIAGE |
| 00817867020641 | CLAMP, 2-HOLE ANGLE |
| 00817867020634 | CLAMP, 7-HOLE STACKED (5, 2) |
| 00817867020627 | CLAMP, 5-HOLE IN-LINE |
| 00817867020610 | CLAMP, 5-HOLE STACKED (4, 1) |
| 00817867020603 | CLAMP, 4-HOLE IN-LINE |
| 00817867020597 | CLAMP, 3-HOLE IN-LINE |
| 00817867020580 | CLAMP, 2-HOLE IN-LINE |
| 00817867020573 | CLAMP, 1-HOLE |
| 00817867020566 | RAIL END CAP |
| 00817867020559 | CARRIAGE, RAIL ARCH |
| 00817867020542 | CARRIAGE, STANDARD |
| 00817867020535 | RAIL ENDCAP, ROTATING, 100 mm |
| 00817867020528 | DRIVE MECHANISM COVER |