Vilex Fibula Tool ZF-D62

GUDID 00841731129987

Tissue Protector, Fibula Nail, 6.2mm

VILEX LLC

Surgical drill guide, reusable

• Primary Device ID: 00841731129987
• NIH Device Record Key: e40e8605-5301-4cb6-8898-dfa5eaffd7c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vilex Fibula Tool
• Version Model Number: ZF-D62
• Catalog Number: ZF-D62
• 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: false
• Device Combination Product: false
• Single Use: false
• 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	00841731129987 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151456

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00841731129987]

Moist Heat or Steam Sterilization

[00841731129987]

Moist Heat or Steam Sterilization

[00841731129987]

Moist Heat or Steam Sterilization

[00841731129987]

Moist Heat or Steam Sterilization

[00841731129987]

Moist Heat or Steam Sterilization

[00841731129987]

Moist Heat or Steam Sterilization

[00841731129987]

Moist Heat or Steam Sterilization

[00841731129987]

Moist Heat or Steam Sterilization

[00841731129987]

Moist Heat or Steam Sterilization

[00841731129987]

Moist Heat or Steam Sterilization

[00841731129987]

Moist Heat or Steam Sterilization

[00841731129987]

Moist Heat or Steam Sterilization

[00841731129987]

Moist Heat or Steam Sterilization

[00841731129987]

Moist Heat or Steam Sterilization

[00841731129987]

Moist Heat or Steam Sterilization

[00841731129987]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-22
• Device Publish Date: 2022-04-14

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• 00841731137531 - NITINEX: 2024-12-13 NITINEX Staple Implant System, 30mm x 30mm, Sterile