| Primary Device ID | 00841731118882 |
| NIH Device Record Key | d44a4019-4d23-4356-ae88-30ae28711c8c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Orthex Tool |
| Version Model Number | H505 |
| Company DUNS | 152008371 |
| Company Name | VILEX IN TENNESSEE, INC. |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841731118882 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841731118882]
Moist Heat or Steam Sterilization
[00841731118882]
Moist Heat or Steam Sterilization
[00841731118882]
Moist Heat or Steam Sterilization
[00841731118882]
Moist Heat or Steam Sterilization
[00841731118882]
Moist Heat or Steam Sterilization
[00841731118882]
Moist Heat or Steam Sterilization
[00841731118882]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-08-05 |
| Device Publish Date | 2019-07-26 |
| 00841731117748 | Orthex Sleeve wire SB 5x4.5x100mm |
| 00841731117731 | Orthex Sleeve wire SB 4.5x1.5x110mm |
| 00841731117717 | Half Pin Removal Tool (LB) |
| 00841731117588 | Half Pin Removal Tool (SB) |
| 00841731117267 | Orthex Wire Sleeve 4.5x1.8x110mm |
| 00841731123268 | Pin Shears, Double Action 22" (4.5-6.0) |
| 00841731123343 | X-Ray Ball Bridge, 280mm |
| 00841731123336 | X-Ray Ball Bridge, 255mm |
| 00841731123350 | X-Ray Ball Bridge, SB 60mm |
| 00841731122117 | 4.8 drill sleeve, Short |
| 00841731122100 | 4.8 drill sleeve, Long |
| 00841731121530 | X-Ray Ball Bridge, 230mm |
| 00841731121523 | X-Ray Ball Bridge, 205mm |
| 00841731121516 | X-Ray Ball Bridge, 180mm |
| 00841731121509 | X-Ray Ball Bridge, 155mm |
| 00841731121493 | X-Ray Ball Bridge, 130mm |
| 00841731121486 | X-Ray Ball Bridge, 105mm |
| 00841731118974 | X-Ray Ball Bridge, SB 130mm |
| 00841731118967 | X-Ray Ball Bridge, SB 110mm |
| 00841731118950 | X-Ray Ball Bridge, SB 95mm |
| 00841731118943 | X-Ray Ball Bridge, SB 75mm |
| 00841731118882 | Orthex, Handle, AO Pull Adpt |