STATIX

GUDID 00841731110022

Ring, Statix Half 160mm Black

VILEX IN TENNESSEE, INC.

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

• Primary Device ID: 00841731110022
• NIH Device Record Key: cf08a0b3-371f-4e4d-8b80-34613f8e925a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STATIX
• Version Model Number: 301-050-160
• 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	00841731110022 [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

[00841731110022]

Moist Heat or Steam Sterilization

[00841731110022]

Moist Heat or Steam Sterilization

[00841731110022]

Moist Heat or Steam Sterilization

[00841731110022]

Moist Heat or Steam Sterilization

[00841731110022]

Moist Heat or Steam Sterilization

[00841731110022]

Moist Heat or Steam Sterilization

[00841731110022]

Moist Heat or Steam Sterilization

[00841731110022]

Moist Heat or Steam Sterilization

[00841731110022]

Moist Heat or Steam Sterilization

[00841731110022]

Moist Heat or Steam Sterilization

[00841731110022]

Moist Heat or Steam Sterilization

[00841731110022]

Moist Heat or Steam Sterilization

[00841731110022]

Moist Heat or Steam Sterilization

[00841731110022]

Moist Heat or Steam Sterilization

[00841731110022]

Moist Heat or Steam Sterilization

[00841731110022]

Moist Heat or Steam Sterilization

[00841731110022]

Moist Heat or Steam Sterilization

[00841731110022]

Moist Heat or Steam Sterilization

[00841731110022]

Moist Heat or Steam Sterilization

[00841731110022]

Moist Heat or Steam Sterilization

[00841731110022]

Moist Heat or Steam Sterilization

[00841731110022]

Moist Heat or Steam Sterilization

[00841731110022]

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 [STATIX]

• 00841731110169: FootPlate, Statix 210mm Black
• 00841731110152: FootPlate, Statix 180mm Black
• 00841731110145: FootPlate, Statix 160mm Black
• 00841731110138: FootPlate, Statix 140mm Black
• 00841731110121: Ring, Statix Full 210mm Black
• 00841731110114: Ring, Statix Full 180mm Black
• 00841731110107: Ring, Statix Full 160mm Black
• 00841731110091: Ring, Statix Full 140mm Black
• 00841731110084: Ring, Statix 5/8 210mm Black
• 00841731110077: Ring, Statix 5/8 180mm Black
• 00841731110060: Ring, Statix 5/8 160mm Black
• 00841731110053: Ring, Statix 5/8 140mm Black
• 00841731110046: Ring, Statix Half 210mm Black
• 00841731110039: Ring, Statix Half 180mm Black
• 00841731110022: Ring, Statix Half 160mm Black
• 00841731110015: Ring, Statix Half 140mm Black
• 00841731110008: Ring, Statix 3/8 210mm Black
• 00841731109996: Ring, Statix 3/8 180mm Black
• 00841731109989: Ring, Statix 3/8 160mm Black
• 00841731109972: Ring, Statix 3/8 140mm Black