Vilex Titanex II Headless

GUDID 00841731113795

Screw, Headless "H" 4.0x28mm_Ti Purple

VILEX IN TENNESSEE, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00841731113795
• NIH Device Record Key: 268df8e9-e0e5-48c0-afb6-1d7d94c08d43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vilex Titanex II Headless
• Version Model Number: H40-28T-14
• 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	00841731113795 [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

[00841731113795]

Moist Heat or Steam Sterilization

[00841731113795]

Moist Heat or Steam Sterilization

[00841731113795]

Moist Heat or Steam Sterilization

[00841731113795]

Moist Heat or Steam Sterilization

[00841731113795]

Moist Heat or Steam Sterilization

[00841731113795]

Moist Heat or Steam Sterilization

[00841731113795]

Moist Heat or Steam Sterilization

[00841731113795]

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: 2017-01-02

On-Brand Devices [Vilex Titanex II Headless]

• 00841731120021: Screw, Headless "H" 2.0x40mm_Ti Blue
• 00841731120014: Screw, Headless "H" 2.0x38mm_Ti Blue
• 00841731120007: Screw, Headless "H" 2.0x36mm_Ti Blue
• 00841731113955: Screw, Headless "H" 4.0x60mm_Ti Purple
• 00841731113948: Screw, Headless "H" 4.0x58mm_Ti Purple
• 00841731113931: Screw, Headless "H" 4.0x56mm_Ti Purple
• 00841731113924: Screw, Headless "H" 4.0x54mm_Ti Purple
• 00841731113917: Screw, Headless "H" 4.0x52mm_Ti Purple
• 00841731113900: Screw, Headless "H" 4.0x50mm_Ti Purple
• 00841731113894: Screw, Headless "H" 4.0x48mm_Ti Purple
• 00841731113887: Screw, Headless "H" 4.0x46mm_Ti Purple
• 00841731113870: Screw, Headless "H" 4.0x44mm_Ti Purple
• 00841731113863: Screw, Headless "H" 4.0x42mm_Ti Purple
• 00841731113856: Screw, Headless "H" 4.0x40mm_Ti Purple
• 00841731113849: Screw, Headless "H" 4.0x38mm_Ti Purple
• 00841731113832: Screw, Headless "H" 4.0x36mm_Ti Purple
• 00841731113825: Screw, Headless "H" 4.0x34mm_Ti Purple
• 00841731113818: Screw, Headless "H" 4.0x32mm_Ti Purple
• 00841731113801: Screw, Headless "H" 4.0x30mm_Ti Purple
• 00841731113795: Screw, Headless "H" 4.0x28mm_Ti Purple
• 00841731113788: Screw, Headless "H" 4.0x26mm_Ti Purple
• 00841731113771: Screw, Headless "H" 4.0x24mm_Ti Purple
• 00841731113764: Screw, Headless "H" 4.0x22mm_Ti Purple
• 00841731113757: Screw, Headless "H" 4.0x20mm_Ti Purple
• 00841731113740: Screw, Headless "H" 3.0x40mm_Ti Aqua
• 00841731113733: Screw, Headless "H" 3.0x38mm_Ti Aqua
• 00841731113726: Screw, Headless "H" 3.0x36mm_Ti Aqua
• 00841731113719: Screw, Headless "H" 3.0x34mm_Ti Aqua
• 00841731113702: Screw, Headless "H" 3.0x32mm_Ti Aqua
• 00841731113696: Screw, Headless "H" 3.0x30mm_Ti Aqua
• 00841731113689: Screw, Headless "H" 3.0x28mm_Ti Aqua
• 00841731113672: Screw, Headless "H" 3.0x26mm_Ti Aqua
• 00841731113665: Screw, Headless "H" 3.0x24mm_Ti Aqua
• 00841731113658: Screw, Headless "H" 3.0x22mm_Ti Aqua
• 00841731113641: Screw, Headless "H" 3.0x20mm_Ti Aqua
• 00841731113634: Screw, Headless "H" 3.0x18mm_Ti Aqua
• 00841731113627: Screw, Headless "H" 3.0x16mm_Ti Aqua
• 00841731113610: Screw, Headless "H" 3.0x14mm_Ti Aqua
• 00841731113603: Screw, Headless "H" 3.0x12mm_Ti Aqua
• 00841731113597: Screw, Headless "H" 3.0x10mm_Ti Aqua
• 00841731113580: Screw, Headless "H" 2.5x40mm_Ti Gold
• 00841731113573: Screw, Headless "H" 2.5x38mm_Ti Gold
• 00841731113566: Screw, Headless "H" 2.5x36mm_Ti Gold
• 00841731113559: Screw, Headless "H" 2.5x34mm_Ti Gold
• 00841731113542: Screw, Headless "H" 2.5x32mm_Ti Gold
• 00841731113535: Screw, Headless "H" 2.5x30mm_Ti Gold
• 00841731113528: Screw, Headless "H" 2.5x28mm_Ti Gold
• 00841731113511: Screw, Headless "H" 2.5x26mm_Ti Gold
• 00841731113504: Screw, Headless "H" 2.5x24mm_Ti Gold
• 00841731113498: Screw, Headless "H" 2.5x22mm_Ti Gold