Vilex Plate WSZ03

GUDID 00841731116970

Sizer, Wedge Plate 3mm

VILEX LLC

Orthopaedic fixation implant alignment tool

• Primary Device ID: 00841731116970
• NIH Device Record Key: ac98a5ba-f512-4f1c-becf-d9f335cd6496
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vilex Plate
• Version Model Number: WSZ03
• Catalog Number: WSZ03
• 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	00841731116970 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041287

FDA Product Code

• HWT: Template

Sterilization

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

[00841731116970]

Moist Heat or Steam Sterilization

[00841731116970]

Moist Heat or Steam Sterilization

[00841731116970]

Moist Heat or Steam Sterilization

[00841731116970]

Moist Heat or Steam Sterilization

[00841731116970]

Moist Heat or Steam Sterilization

[00841731116970]

Moist Heat or Steam Sterilization

[00841731116970]

Moist Heat or Steam Sterilization

[00841731116970]

Moist Heat or Steam Sterilization

[00841731116970]

Moist Heat or Steam Sterilization

[00841731116970]

Moist Heat or Steam Sterilization

[00841731116970]

Moist Heat or Steam Sterilization

[00841731116970]

Moist Heat or Steam Sterilization

[00841731116970]

Moist Heat or Steam Sterilization

[00841731116970]

Moist Heat or Steam Sterilization

[00841731116970]

Moist Heat or Steam Sterilization

[00841731116970]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-20
• Device Publish Date: 2021-05-12

On-Brand Devices [Vilex Plate]

• 00841731117007: Sizer, Wedge Plate 6mm
• 00841731116994: Sizer, Wedge Plate 5mm
• 00841731116987: Sizer, Wedge Plate 4mm
• 00841731116970: Sizer, Wedge Plate 3mm
• 00841731116963: Sizer, Wedge Plate 2mm