eZ-Fix

GUDID 00841731111586

Wrench, Ratchet

VILEX IN TENNESSEE, INC.

External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use

• Primary Device ID: 00841731111586
• NIH Device Record Key: e124d382-a320-4c9a-8471-d825ac01b680
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eZ-Fix
• Version Model Number: 920-RW-10
• 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	00841731111586 [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

[00841731111586]

Moist Heat or Steam Sterilization

[00841731111586]

Moist Heat or Steam Sterilization

[00841731111586]

Moist Heat or Steam Sterilization

[00841731111586]

Moist Heat or Steam Sterilization

[00841731111586]

Moist Heat or Steam Sterilization

[00841731111586]

Moist Heat or Steam Sterilization

[00841731111586]

Moist Heat or Steam Sterilization

[00841731111586]

Moist Heat or Steam Sterilization

[00841731111586]

Moist Heat or Steam Sterilization

[00841731111586]

Moist Heat or Steam Sterilization

[00841731111586]

Moist Heat or Steam Sterilization

[00841731111586]

Moist Heat or Steam Sterilization

[00841731111586]

Moist Heat or Steam Sterilization

[00841731111586]

Moist Heat or Steam Sterilization

[00841731111586]

Moist Heat or Steam Sterilization

[00841731111586]

Moist Heat or Steam Sterilization

[00841731111586]

Moist Heat or Steam Sterilization

[00841731111586]

Moist Heat or Steam Sterilization

[00841731111586]

Moist Heat or Steam Sterilization

[00841731111586]

Moist Heat or Steam Sterilization

[00841731111586]

Moist Heat or Steam Sterilization

[00841731111586]

Moist Heat or Steam Sterilization

[00841731111586]

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