| Primary Device ID | 00841132178102 |
| NIH Device Record Key | 3edf4961-86a3-4f2c-a9af-f877effe9b20 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Orthex Tool |
| Version Model Number | H505 |
| Catalog Number | H505 |
| 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 | false |
| Serial Number | true |
| 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 | 00841132178102 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841132178102]
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 |
| 00841132180587 | X-Ray Ball Bridge, 280mm |
| 00841132180570 | X-Ray Ball Bridge, 255mm |
| 00841132180563 | X-Ray Ball Bridge, 230mm |
| 00841132180556 | X-Ray Ball Bridge, 205mm |
| 00841132180549 | X-Ray Ball Bridge, 180mm |
| 00841132180532 | X-Ray Ball Bridge, 155mm |
| 00841132180525 | X-Ray Ball Bridge, 130mm |
| 00841132180518 | X-Ray Ball Bridge, 105mm |
| 00841132179192 | Half Pin Removal Tool, Adult |
| 00841132179185 | Half Pin Removal Tool, Ped |
| 00841132177877 | X-Ray Ball Bridge, Small Bone 130mm |
| 00841132177860 | X-Ray Ball Bridge, Small Bone 110mm |
| 00841132177853 | X-Ray Ball Bridge, Small Bone 95mm |
| 00841132177846 | X-Ray Ball Bridge, Small Bone 75mm |
| 00841132177839 | X-Ray Ball Bridge, Small Bone 60mm |
| 00841132180648 | 2.0MM DIA. NEUTRAL & LOAD END GREEN/GOLD DRILL GUIDE |
| 00841132179949 | Drill Sleeve, SB 5.0x4.5x100mm |
| 00841132179888 | Wire Sleeve, SB 4.5x1.5x110mm |
| 00841132179871 | 4.8 drill sleeve, Short |
| 00841132179864 | 4.8 drill sleeve, Long |
| 00841132179789 | Wire Sleeve 4.5x1.8x110mm |
| 00841132178102 | Orthex, Handle, AO Pull Adpt |