DLIF DISC PREP

GUDID 00841732165694

Cobb Elevator, Bent, Angled, 13mm

CTL Medical Corporation

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00841732165694
• NIH Device Record Key: d7aa368d-4c22-4fd8-be8e-fbeeaf619433
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DLIF DISC PREP
• Version Model Number: 104.7016
• 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
• 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	00841732165694 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131981

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00841732165694]

Moist Heat or Steam Sterilization

[00841732165694]

Moist Heat or Steam Sterilization

[00841732165694]

Moist Heat or Steam Sterilization

[00841732165694]

Moist Heat or Steam Sterilization

[00841732165694]

Moist Heat or Steam Sterilization

[00841732165694]

Moist Heat or Steam Sterilization

[00841732165694]

Moist Heat or Steam Sterilization

[00841732165694]

Moist Heat or Steam Sterilization

[00841732165694]

Moist Heat or Steam Sterilization

[00841732165694]

Moist Heat or Steam Sterilization

[00841732165694]

Moist Heat or Steam Sterilization

[00841732165694]

Moist Heat or Steam Sterilization

[00841732165694]

Moist Heat or Steam Sterilization

[00841732165694]

Moist Heat or Steam Sterilization

[00841732165694]

Moist Heat or Steam Sterilization

[00841732165694]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-04
• Device Publish Date: 2024-09-26

On-Brand Devices [DLIF DISC PREP]

• 00841732165847: Ring Curette, Bent, Triangle, W11mm
• 00841732165779: Curette, Bent, 15Deg. Angled Size 4 (W9.7mm)
• 00841732165762: Curette, Bent, 15Deg. Angled Size 2 (W7.9mm)
• 00841732165755: Curette, Bent, Straight, Size 4 (W9.7mm)
• 00841732165748: Curette, Bent, Straight, Size 2 (W7.9mm)
• 00841732165731: Ring Curette, Bent, Tear Drop, Straight, W9mm
• 00841732165724: Double Sided Rasp, Bent, Straight W13xL24mm
• 00841732165717: Cobb Elevator, Bent, Angled, 22mm
• 00841732165700: Cobb Elevator, Bent, Angled, 18mm
• 00841732165694: Cobb Elevator, Bent, Angled, 13mm
• 00841732166554: DLIF Cage Inserter, Straight