Valeo II LL

GUDID 00841732167322

Valeo II LL Extractor

CTL Medical Corporation

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00841732167322
• NIH Device Record Key: 5623cbf3-50d2-41d2-be31-2cc27bcce808
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Valeo II LL
• Version Model Number: 91.020.1099
• Company DUNS: 080138504
• Company Name: CTL Medical Corporation
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841732167322 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121892

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00841732167322]

Moist Heat or Steam Sterilization

[00841732167322]

Moist Heat or Steam Sterilization

[00841732167322]

Moist Heat or Steam Sterilization

[00841732167322]

Moist Heat or Steam Sterilization

[00841732167322]

Moist Heat or Steam Sterilization

[00841732167322]

Moist Heat or Steam Sterilization

[00841732167322]

Moist Heat or Steam Sterilization

[00841732167322]

Moist Heat or Steam Sterilization

[00841732167322]

Moist Heat or Steam Sterilization

[00841732167322]

Moist Heat or Steam Sterilization

[00841732167322]

Moist Heat or Steam Sterilization

[00841732167322]

Moist Heat or Steam Sterilization

[00841732167322]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-11
• Device Publish Date: 2024-11-01

On-Brand Devices [Valeo II LL]

• 00841732128729: 042.7700
• 00841732167322: Valeo II LL Extractor
• 00841732165236: VALEO II LL Slap Hammer Adapter
• 00841732158672: K Wire
• 00841732158665: Blade Extension, Trocar
• 00841732158658: Blade Extension, Shim