PICASSO™ II MIS Spinal System 019.8155

GUDID 00841732109544

PICASSO™ II MIS Spinal System Implant Tray, 5.5 Screws

CTL Medical Corporation

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• Primary Device ID: 00841732109544
• NIH Device Record Key: acca197e-fd0b-4501-a359-d47212f88322
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PICASSO™ II MIS Spinal System
• Version Model Number: 019.8155
• Catalog Number: 019.8155
• 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: true
• 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

Customer Support Contacts

• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841732109544 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140219

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[00841732109544]

Moist Heat or Steam Sterilization

[00841732109544]

Moist Heat or Steam Sterilization

[00841732109544]

Moist Heat or Steam Sterilization

[00841732109544]

Moist Heat or Steam Sterilization

[00841732109544]

Moist Heat or Steam Sterilization

[00841732109544]

Moist Heat or Steam Sterilization

[00841732109544]

Moist Heat or Steam Sterilization

[00841732109544]

Moist Heat or Steam Sterilization

[00841732109544]

Moist Heat or Steam Sterilization

[00841732109544]

Moist Heat or Steam Sterilization

[00841732109544]

Moist Heat or Steam Sterilization

[00841732109544]

Moist Heat or Steam Sterilization

[00841732109544]

Moist Heat or Steam Sterilization

[00841732109544]

Moist Heat or Steam Sterilization

[00841732109544]

Moist Heat or Steam Sterilization

[00841732109544]

Moist Heat or Steam Sterilization

[00841732109544]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-15
• Device Publish Date: 2024-05-07

On-Brand Devices [PICASSO™ II MIS Spinal System ]

• 00841732109513: PICASSO™ II MIS Spinal System Implant Case, D6.0 Curved Rods / Set Screws
• 00841732109506: PICASSO™ II MIS Spinal System Implant Case
• 00841732109575: PICASSO™ II MIS Spinal System Instrument Sterilization Case
• 00841732109568: PICASSO™ II MIS Spinal System Implant Tray, 7.5 Screws
• 00841732109551: PICASSO™ II MIS Spinal System Implant Tray, 6.5 Screws
• 00841732109544: PICASSO™ II MIS Spinal System Implant Tray, 5.5 Screws
• 00841732109537: Set Screw Module
• 00841732109520: PICASSO™ II MIS Spinal System Implant Tray, D6.0 Straight Rods