eZ-Fix
GUDID 00841731111593
Wrench, T 3.0mm
VILEX IN TENNESSEE, INC.
External orthopaedic fixation system, single-use, non-sterile| Primary Device ID | 00841731111593 |
| NIH Device Record Key | b9aea150-76d8-4009-94cd-75062dacae0e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | eZ-Fix |
| Version Model Number | 925-TW-30 |
| Company DUNS | 152008371 |
| Company Name | VILEX IN TENNESSEE, INC. |
| 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 | true |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841731111593 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K052196
FDA Product Code
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841731111593]
Moist Heat or Steam Sterilization
[00841731111593]
Moist Heat or Steam Sterilization
[00841731111593]
Moist Heat or Steam Sterilization
[00841731111593]
Moist Heat or Steam Sterilization
[00841731111593]
Moist Heat or Steam Sterilization
[00841731111593]
Moist Heat or Steam Sterilization
[00841731111593]
Moist Heat or Steam Sterilization
[00841731111593]
Moist Heat or Steam Sterilization
[00841731111593]
Moist Heat or Steam Sterilization
[00841731111593]
Moist Heat or Steam Sterilization
[00841731111593]
Moist Heat or Steam Sterilization
[00841731111593]
Moist Heat or Steam Sterilization
[00841731111593]
Moist Heat or Steam Sterilization
[00841731111593]
Moist Heat or Steam Sterilization
[00841731111593]
Moist Heat or Steam Sterilization
[00841731111593]
Moist Heat or Steam Sterilization
[00841731111593]
Moist Heat or Steam Sterilization
[00841731111593]
Moist Heat or Steam Sterilization
[00841731111593]
Moist Heat or Steam Sterilization
[00841731111593]
Moist Heat or Steam Sterilization
[00841731111593]
Moist Heat or Steam Sterilization
[00841731111593]
Moist Heat or Steam Sterilization
[00841731111593]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-29 |
On-Brand Devices [eZ-Fix]
| 00841731119971 | Half Pin, 3.0 x 75mm w/ 30mm TL |
| 00841731119964 | Half Pin, 3.0 x 75mm w/ 25mm TL |
| 00841731119957 | Half Pin, 3.0 x 75mm w/ 20mm TL |
| 00841731119940 | Half Pin, 3.0 x 75mm w/ 15mm TL |
| 00841731119933 | Half Pin, 2.5 x 75mm w/ 20mm TL |
| 00841731119926 | Half Pin, 2.5 x 75mm w/ 15mm TL |
| 00841731119919 | Half Pin, 2.0 x 75mm w/ 12mm TL |
| 00841731119902 | Half Pin, 2.0 x 75mm w/ 10mm TL |
| 00841731119896 | Half Pin, 2.0 x 75mm w/ 08mm TL |
| 00841731119889 | Bolt, 25mm |
| 00841731119872 | Wrench, Combo 13mm |
| 00841731119841 | Bolt, Half Pin Washerless |
| 00841731119797 | Rail, Mono 250mm Blue |
| 00841731119780 | Rail, Mono 200mm Blue |
| 00841731119773 | Spring, Shoe Suspension (4/pk) |
| 00841731119766 | Hinge, Multi-angle ball |
| 00841731119759 | Post, 1 Hole Male - Long |
| 00841731119735 | Post, 1 Hole Female Long |
| 00841731119186 | Rail, Micro 90mm w/3 Stationary Carriages |
| 00841731118745 | Rail, Tool 750mm Hex Key |
| 00841731118738 | Rail , Half Moon Half-Pin Inserter |
| 00841731118592 | Rail, Micro 100mm w/4 Fixed Carriages |
| 00841731117076 | Nut, 10mmx6mm |
| 00841731115270 | Wire Trocar 1.5 x 400mm |
| 00841731115249 | Wire Drill Tip Olive 1.5x400mm |
| 00841731115232 | Wire Drill Tip 1.5x400mm |
| 00841731115225 | Wire ConeShape Drill Tip 1.5x400mm |
| 00841731115201 | Wire Bayonet Olive 1.5x400mm |
| 00841731115164 | Wire Bayonet 1.5x400mm |
| 00841731114730 | Arch, 90mm Short |
| 00841731111845 | Distractor/Clicker, Linear 200mm Black |
| 00841731111838 | Distractor/Clicker, Linear 150mm Black |
| 00841731111821 | Distractor/Clicker, Linear 100mm Black |
| 00841731111814 | Drill guide, Half Pin |
| 00841731111807 | Hinge clamp, Ball and ring |
| 00841731111791 | Nut, Multi angle hinge 10mm |
| 00841731111784 | HInge, 90 degree |
| 00841731111777 | Hinge, Universal |
| 00841731111760 | 45 degree male ball hinge |
| 00841731111753 | 45 degree female ball hinge |
| 00841731111746 | Wire Trocar 1.8x400mm |
| 00841731111739 | Wire Trocar Olive 1.8x400mm |
| 00841731111722 | Wire Drill Tip Olive 1.8x400mm |
| 00841731111715 | Wire Drill tip 1.8x400mm |
| 00841731111708 | Wire Bayonet Pear 1.8x400mm |
| 00841731111692 | Wire Bayonet 1.8x400mm |
| 00841731111685 | Shoe, eZ-FIX (Pair) |
| 00841731111678 | Rail, Mini 100mm Gold |
| 00841731111661 | Rail, Mini 80mm Gold |
| 00841731111654 | Rail, Mini 100mm Black |
Trademark Results [eZ-Fix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EZ-FIX 77523634 3894330 Live/Registered |
Vilex in Tennessee, Inc. 2008-07-16 |
 EZ-FIX 75012125 2257418 Dead/Cancelled |
BIODYNAMIC TECHNOLOGIES, INC. 1995-10-30 |
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