Vilex Jones Fracture Tool

GUDID 00841731123213

Drill/Tap Guide, JF 4.5mmScrews

VILEX IN TENNESSEE, INC.

Surgical drill guide, reusable

• Primary Device ID: 00841731123213
• NIH Device Record Key: d2d5defa-8967-454e-8aad-32330e062b5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vilex Jones Fracture Tool
• Version Model Number: JF-Guide-45
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841731123213 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191289

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00841731123213]

Moist Heat or Steam Sterilization

[00841731123213]

Moist Heat or Steam Sterilization

[00841731123213]

Moist Heat or Steam Sterilization

[00841731123213]

Moist Heat or Steam Sterilization

[00841731123213]

Moist Heat or Steam Sterilization

[00841731123213]

Moist Heat or Steam Sterilization

[00841731123213]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-02
• Device Publish Date: 2019-08-23

On-Brand Devices [Vilex Jones Fracture Tool]

• 00841731123244: Guide, Jones Fracture Wire
• 00841731123237: Drill/Tap Guide, JF 6.0mm Screws
• 00841731123220: Drill/Tap Guide, JF 5.5mmScrews
• 00841731123213: Drill/Tap Guide, JF 4.5mmScrews
• 00841731123251: Depth Gauge, Jone Fracture 200mm
• 00841731123206: Driver, Jones T20 Hexalobe, Solid, Non Self Retaining
• 00841731123190: Driver, Jones T20 Hexalobe, Non Self Retaining
• 00841731123183: Driver, Jones T20 Hexalobe, Solid Self Retaining
• 00841731123176: Driver, Jones, Hexalobe T20, Self Retaining
• 00841731123169: Countersink, Jones Fracture 6.0mm
• 00841731123152: Countersink, Jones Fracture 5.5mm
• 00841731123145: Countersink, Jones Fracture 4.5mm
• 00841731123138: Tap, Jones Fracture, 6.0mm
• 00841731123121: Tap, Jones Fracture, 5.5mm
• 00841731123114: Tap, Jones Fracture, 4.5mm