TACTIX Vector TVX-TSNR-K

GUDID 00841731133861

TACTIX Vector Tensioner Kit

VILEX LLC

Suture/ligature tightener, single-use

• Primary Device ID: 00841731133861
• NIH Device Record Key: 0813b61c-e0fe-43f2-b541-3ffec98431de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TACTIX Vector
• Version Model Number: TVX-TSNR-K
• Catalog Number: TVX-TSNR-K
• Company DUNS: 117502293
• Company Name: VILEX LLC
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00841731133861 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240035

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-14
• Device Publish Date: 2025-08-06

On-Brand Devices [TACTIX Vector]

• 00841731136442: TACTIX Vector Suture Kit
• 00841731133861: TACTIX Vector Tensioner Kit