Vilex Jones Fracture Guidewire

GUDID 00841731123084

Wire, Guide 1.8x200mm Sgl Trocar

VILEX IN TENNESSEE, INC.

Orthopaedic bone wire

• Primary Device ID: 00841731123084
• NIH Device Record Key: c0502863-b552-4cd3-9e5f-8c1e2a4b69fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vilex Jones Fracture Guidewire
• Version Model Number: K200-18T
• 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	00841731123084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191289

FDA Product Code

• HXI: Passer, Wire, Orthopedic

Sterilization

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

[00841731123084]

Moist Heat or Steam Sterilization

[00841731123084]

Moist Heat or Steam Sterilization

[00841731123084]

Moist Heat or Steam Sterilization

[00841731123084]

Moist Heat or Steam Sterilization

[00841731123084]

Moist Heat or Steam Sterilization

[00841731123084]

Moist Heat or Steam Sterilization

[00841731123084]

Moist Heat or Steam Sterilization

[00841731123084]

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 Guidewire]

• 00841731123558: Wire, Guide 1.8x200mm Sgl Trocar
• 00841731123084: Wire, Guide 1.8x200mm Sgl Trocar