PICASSO II

GUDID 00841732118133

CTL MEDICAL CORPORATION

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00841732118133
• NIH Device Record Key: 5421469c-106c-4fbc-add3-a1eee89951da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PICASSO II
• Version Model Number: 129. 0530
• 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: true
• 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: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.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
• 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
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841732118133 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140219

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

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

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

[00841732118133]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-07

On-Brand Devices [PICASSO II]

• 00841732119390: 019.1890
• 00841732119383: 019.1885
• 00841732119376: 019.1880
• 00841732119369: 019.1875
• 00841732119352: 019.1870
• 00841732119345: 019.1865
• 00841732119338: 019.1860
• 00841732119321: 019.1855
• 00841732119314: 019.1850
• 00841732119307: 019.1845
• 00841732119291: 019.1840
• 00841732119284: 119.1890
• 00841732119277: 119.1885
• 00841732119260: 119.1880
• 00841732119253: 119.1875
• 00841732119246: 119.1870
• 00841732119239: 119.1865
• 00841732119222: 119.1860
• 00841732119215: 119.1855
• 00841732119208: 119.1850
• 00841732119192: 119.1845
• 00841732119185: 119.1840
• 00841732119178: 119.1835
• 00841732119161: 119.1830
• 00841732119154: 119.1790
• 00841732119147: 119.1785
• 00841732119130: 119.1780
• 00841732119123: 119.1775
• 00841732119116: 119.1770
• 00841732119109: 119.1765
• 00841732119093: 119.1760
• 00841732119086: 119.1755
• 00841732119079: 119.1730
• 00841732119062: 119.1630
• 00841732119055: 119.1530
• 00841732119048: 119.1565
• 00841732119031: 119.1560
• 00841732119024: 119.1555
• 00841732119017: 119.1550
• 00841732118980: 119.1665
• 00841732118973: 119.1660
• 00841732118966: 119.1655
• 00841732118959: 119.1650
• 00841732118287: 129.7051
• 00841732118270: 129.7050
• 00841732118263: 129. 0760
• 00841732118256: 129. 0755
• 00841732118249: 129. 0750
• 00841732118232: 129. 0745
• 00841732118225: 129. 0740