| Primary Device ID | 00841132179918 |
| NIH Device Record Key | 2697dff8-f39f-4348-a4e0-185eaad9d888 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vilex Tool |
| Version Model Number | PP460-27-75 |
| Catalog Number | PP460-27-75 |
| Company DUNS | 796416191 |
| Company Name | ORTHOPEDIATRICS CORP. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 |
| bsmith@orthopediatrics.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841132179918 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841132179918]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-10 |
| Device Publish Date | 2020-03-02 |
| 00841132180662 | Pin Cutter, Double Action |
| 00841132180655 | Wire Cutter & Bending Pliers |
| 00841132180631 | Wire Cutter & Bending Pliers |
| 00841132180624 | Rail Tray |
| 00841132180617 | Strut & Hardware Tray |
| 00841132180600 | Ring Tray |
| 00841132178751 | Tray, Orthex Drill |
| 00841132177921 | Orthex Small Bone Ring Tray |
| 00841132177914 | Orthex Small Bone Drill Tray |
| 00841132177907 | Orthex Small Bone Cubes & Struts Tray |
| 00841132177891 | Orthex Small Bone Hardware Tray |
| 00841132181003 | Orthex, Hex Driver, 3mm |
| 00841132180990 | Orthex, Hex Driver, 2mm |
| 00841132180709 | Tensioner, Short Nose |
| 00841132179932 | Orthex Sleeve wire SB 3.5x75mm |
| 00841132179925 | Orthex Sleeve wire SB 3.5x155mm |
| 00841132179918 | Orthex Sleeve wire SB 2.7x75mm |
| 00841132179901 | Orthex Sleeve wire SB 2.7x155mm |
| 00841132179895 | Orthex Sleeve wire SB 2.0x75mm |
| 00841132179857 | 4.5 drill sleeve, Short |
| 00841132179840 | 4.5 drill sleeve, Long |
| 00841132179833 | Wire Sleeve 6.0x4.5x100mm |
| 00841132179826 | 3.2 drill sleeve, Short |
| 00841132179819 | 3.2 drill sleeve, Long |
| 00841132179802 | 2.0 drill sleeve, Short |
| 00841132179796 | 2.0 drill sleeve, Long |