AL Disc Prep

GUDID 00841732166424

Removable Wedge Distractor Tip, H9mm

CTL Medical Corporation

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00841732166424
• NIH Device Record Key: 4e6cd967-09bc-46df-942c-934649ea5a48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AL Disc Prep
• Version Model Number: 106.7079
• 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	00841732166424 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192863

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00841732166424]

Moist Heat or Steam Sterilization

[00841732166424]

Moist Heat or Steam Sterilization

[00841732166424]

Moist Heat or Steam Sterilization

[00841732166424]

Moist Heat or Steam Sterilization

[00841732166424]

Moist Heat or Steam Sterilization

[00841732166424]

Moist Heat or Steam Sterilization

[00841732166424]

Moist Heat or Steam Sterilization

[00841732166424]

Moist Heat or Steam Sterilization

[00841732166424]

Moist Heat or Steam Sterilization

[00841732166424]

Moist Heat or Steam Sterilization

[00841732166424]

Moist Heat or Steam Sterilization

[00841732166424]

Moist Heat or Steam Sterilization

[00841732166424]

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 [AL Disc Prep]

• 00841732166479: Removable Wedge Distractor Tip, H19mm
• 00841732166462: Removable Wedge Distractor Tip, H17mm
• 00841732166455: Removable Wedge Distractor Tip, H15mm
• 00841732166448: Removable Wedge Distractor Tip, H13mm
• 00841732166431: Removable Wedge Distractor Tip, H11mm
• 00841732166424: Removable Wedge Distractor Tip, H9mm
• 00841732166547: Modular Rasp, ALIF, 9Deg, W34xL23, H21mm
• 00841732166530: Modular Rasp, ALIF, 9Deg, W34xL23, H19mm
• 00841732166523: Modular Rasp, ALIF, 9Deg, W34xL23, H17mm
• 00841732166516: Modular Rasp, ALIF, 9Deg, W34xL23, H15mm
• 00841732166509: Modular Rasp, ALIF, 9Deg, W34xL23, H13mm
• 00841732166493: Modular Rasp, ALIF, 9Deg, W34xL23, H11mm
• 00841732166486: Modular Rasp, ALIF, 9Deg, W34xL23, H9mm