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GUDID 00841732166622

Extended Driver

CTL Medical Corporation

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00841732166622
• NIH Device Record Key: 113a087c-37bd-4299-83cb-86a7f672a118
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navigation
• Version Model Number: 109.7952
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841732166622 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213491

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[00841732166622]

Moist Heat or Steam Sterilization

[00841732166622]

Moist Heat or Steam Sterilization

[00841732166622]

Moist Heat or Steam Sterilization

[00841732166622]

Moist Heat or Steam Sterilization

[00841732166622]

Moist Heat or Steam Sterilization

[00841732166622]

Moist Heat or Steam Sterilization

[00841732166622]

Moist Heat or Steam Sterilization

[00841732166622]

Moist Heat or Steam Sterilization

[00841732166622]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-11
• Device Publish Date: 2024-12-03

On-Brand Devices [Navigation]

• 00841732165243: Navigation Driver, Adjustable, Non-Cannulated, T25
• 00841732165250: Navigation Driver, Adjustable, Non-Cannulated, Hex 4.0
• 00841732166776: NAVIGATION ADAPTER, RENOIR TAP, AO QC
• 00841732166769: NAVIGATION ADAPTER, RENOIR DRIVER, AO QC
• 00841732166639: Taurus Tap Extender (Creo MIS Compatible)
• 00841732166622: Extended Driver
• 00841732166615: Extended Driver