PICASSO MIS Spinal System

GUDID 00841732108530

Percutaneous Curved Rod, D6.0 x L65mm

CTL MEDICAL CORPORATION

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00841732108530
• NIH Device Record Key: 0bd77fe0-e50a-48d9-ad58-3157e337e70a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PICASSO MIS Spinal System
• Version Model Number: 016.3065
• 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: true
• 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 Dimensions

• Length: 65 Millimeter
• Length: 65 Millimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00841732108530 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120714

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

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

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

Moist Heat or Steam Sterilization

[00841732108530]

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: 2016-03-07

On-Brand Devices [PICASSO MIS Spinal System]

• 00841732109001: Cutter, Sleeve, Type 2
• 00841732108998: Anti-Torque Device
• 00841732108981: Hex Driver with Torque Limiting T-Handle, 4.5
• 00841732108974: Hex Driver, Shaft, 1/4" Square Male QC, 4.5
• 00841732108967: Hex Driver with Handle, Self-Retention, 4.5
• 00841732108950: Hex Driver with Handle, 3.0
• 00841732108943: Rod Inserter
• 00841732108936: Alignment Tool, Percutaneous Screw Head
• 00841732108929: Hex Driver, Cannulated, 1/4" Square QC, 4.0 Self-Retention
• 00841732108912: Hex Driver, Cannulated, 1/4" Square Male QC, 4.0
• 00841732108905: Tap, Cannulated, 1/4" Square Male QC, 6.5
• 00841732108899: Tap, Cannulated, 1/4" Square Male QC, 5.5
• 00841732108882: Tap, Cannulated, 1/4" Square Male QC, 4.5
• 00841732108875: Drill, Trilobe End, D3.4 (for 4.5/5.0/5.5 Screws)
• 00841732108868: Dilator, ID14 x OD17mm
• 00841732108851: Dilator, ID10 x OD14mm
• 00841732108844: Dilator, ID1.8 x OD10mm
• 00841732108837: Percutaneous Straight Rod, D6.0 x L200mm
• 00841732108820: Percutaneous Straight Rod, D6.0 x L160mm
• 00841732108813: Percutaneous Straight Rod, D6.0 x L150mm
• 00841732108806: Percutaneous Straight Rod, D6.0 x L140mm
• 00841732108790: Percutaneous Straight Rod, D6.0 x L130mm
• 00841732108783: Percutaneous Straight Rod, D6.0 x L120mm
• 00841732108776: Percutaneous Straight Rod, D6.0 x L110mm
• 00841732108769: Percutaneous Straight Rod, D6.0 x L100mm
• 00841732108752: Percutaneous Straight Rod, D6.0 x L90mm
• 00841732108745: Percutaneous Straight Rod, D6.0 x L80mm
• 00841732108738: Percutaneous Straight Rod, D6.0 x L70mm
• 00841732108721: Percutaneous Straight Rod, D6.0 x L65mm
• 00841732108714: Percutaneous Straight Rod, D6.0 x L60mm
• 00841732108707: Percutaneous Straight Rod, D6.0 x L55mm
• 00841732108691: Percutaneous Straight Rod, D6.0 x L50mm
• 00841732108684: Percutaneous Straight Rod, D6.0 x L45mm
• 00841732108677: Percutaneous Straight Rod, D6.0 x L40mm
• 00841732108660: Percutaneous Straight Rod, D6.0 x L35mm
• 00841732108653: Percutaneous Curved Rod, D6.0 x L150mm
• 00841732108646: Percutaneous Curved Rod, D6.0 x L140mm
• 00841732108639: Percutaneous Curved Rod, D6.0 x L130mm
• 00841732108622: Percutaneous Curved Rod, D6.0 x L120mm
• 00841732108615: Percutaneous Curved Rod, D6.0 x L110mm
• 00841732108608: Percutaneous Curved Rod, D6.0 x L100mm
• 00841732108592: Percutaneous Curved Rod, D6.0 x L95mm
• 00841732108585: Percutaneous Curved Rod, D6.0 x L90mm
• 00841732108578: Percutaneous Curved Rod, D6.0 x L85mm
• 00841732108561: Percutaneous Curved Rod, D6.0 x L80mm
• 00841732108554: Percutaneous Curved Rod, D6.0 x L75mm
• 00841732108547: Percutaneous Curved Rod, D6.0 x L70mm
• 00841732108530: Percutaneous Curved Rod, D6.0 x L65mm
• 00841732108523: Percutaneous Curved Rod, D6.0 x L60mm
• 00841732108516: Percutaneous Curved Rod, D6.0 x L55mm