Talex

GUDID 00841731106476

Talex Implant 05mm_Ti Bronze

VILEX IN TENNESSEE, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00841731106476
• NIH Device Record Key: 6f45502e-529b-4b00-97ad-917feb6e6227
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Talex
• Version Model Number: TAL-05T
• 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	00841731106476 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041289

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00841731106476]

Moist Heat or Steam Sterilization

[00841731106476]

Moist Heat or Steam Sterilization

[00841731106476]

Moist Heat or Steam Sterilization

[00841731106476]

Moist Heat or Steam Sterilization

[00841731106476]

Moist Heat or Steam Sterilization

[00841731106476]

Moist Heat or Steam Sterilization

[00841731106476]

Moist Heat or Steam Sterilization

[00841731106476]

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: 2016-08-03

On-Brand Devices [Talex]

• 00841731114693: Talex Implant 08mm Long_Ti Jade
• 00841731114686: Talex Implant 07mm Long_Ti Green
• 00841731114679: Talex Implant 06mm Long_Ti Gold
• 00841731114662: Talex Implant 05mm Long_Ti Bronze
• 00841731106520: Talex Implant 10mm_Ti Purple
• 00841731106513: Talex Implant 09mm_Ti M.Blue
• 00841731106506: Talex Implant 08mm_Ti Jade
• 00841731106490: Talex Implant 07mm_Ti Green
• 00841731106483: Talex Implant 06mm_Ti Gold
• 00841731106476: Talex Implant 05mm_Ti Bronze