Fibula Nail ZF-RDX

GUDID 00841731136527

Clamp, Fibula, Syndesmotic

VILEX LLC

Bone approximation clamp

• Primary Device ID: 00841731136527
• NIH Device Record Key: fd2940ae-ac2e-443e-a496-9ed03f2cb351
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fibula Nail
• Version Model Number: ZF-RDX
• Catalog Number: ZF-RDX
• 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	00841731136527 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151456

FDA Product Code

• GDJ: Clamp, Surgical, General & Plastic Surgery

Sterilization

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

[00841731136527]

Moist Heat or Steam Sterilization

[00841731136527]

Moist Heat or Steam Sterilization

[00841731136527]

Moist Heat or Steam Sterilization

[00841731136527]

Moist Heat or Steam Sterilization

[00841731136527]

Moist Heat or Steam Sterilization

[00841731136527]

Moist Heat or Steam Sterilization

[00841731136527]

Moist Heat or Steam Sterilization

[00841731136527]

Moist Heat or Steam Sterilization

[00841731136527]

Moist Heat or Steam Sterilization

[00841731136527]

Moist Heat or Steam Sterilization

[00841731136527]

Moist Heat or Steam Sterilization

[00841731136527]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-09
• Device Publish Date: 2022-12-01

On-Brand Devices [Fibula Nail]

• 00841731136527: Clamp, Fibula, Syndesmotic
• 00841731136367: Fibula, Mallet