Dual Thread Screw

GUDID 00841731100542

Screw, Headless 3.0x16mm_Ti Green

VILEX IN TENNESSEE, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00841731100542
• NIH Device Record Key: a0fcdabf-49c3-4e5b-a88b-1dbadae108a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dual Thread Screw
• Version Model Number: F30-16T-11
• 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	00841731100542 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K014154

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00841731100542]

Moist Heat or Steam Sterilization

[00841731100542]

Moist Heat or Steam Sterilization

[00841731100542]

Moist Heat or Steam Sterilization

[00841731100542]

Moist Heat or Steam Sterilization

[00841731100542]

Moist Heat or Steam Sterilization

[00841731100542]

Moist Heat or Steam Sterilization

[00841731100542]

Moist Heat or Steam Sterilization

[00841731100542]

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: 2016-07-22

On-Brand Devices [Dual Thread Screw]

• 00841731100641: Screw, Headless 3.0x26mm ST_Ti Gold
• 00841731100627: Screw, Headless 3.0x24mm ST_Ti Gold
• 00841731100542: Screw, Headless 3.0x16mm_Ti Green
• 00841731100009: Screw, Headless 2.0x06mm_Ti Green