PASS LP PASS TL

GUDID 03613720295655

HOOK B22110010 TP 0-10

MEDICREA INTERNATIONAL

Bone-screw internal spinal fixation system hook

• Primary Device ID: 03613720295655
• NIH Device Record Key: 41887dec-93b3-42db-9fe5-1994e7e7a1f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PASS LP PASS TL
• Version Model Number: B22110010
• Company DUNS: 383228632
• Company Name: MEDICREA INTERNATIONAL
• 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(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03613720295655 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162786

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[03613720295655]

Moist Heat or Steam Sterilization

[03613720295655]

Moist Heat or Steam Sterilization

[03613720295655]

Moist Heat or Steam Sterilization

[03613720295655]

Moist Heat or Steam Sterilization

[03613720295655]

Moist Heat or Steam Sterilization

[03613720295655]

Moist Heat or Steam Sterilization

[03613720295655]

Moist Heat or Steam Sterilization

[03613720295655]

Moist Heat or Steam Sterilization

[03613720295655]

Moist Heat or Steam Sterilization

[03613720295655]

Moist Heat or Steam Sterilization

[03613720295655]

Moist Heat or Steam Sterilization

[03613720295655]

Moist Heat or Steam Sterilization

[03613720295655]

Moist Heat or Steam Sterilization

[03613720295655]

Moist Heat or Steam Sterilization

[03613720295655]

Moist Heat or Steam Sterilization

[03613720295655]

Moist Heat or Steam Sterilization

[03613720295655]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-05
• Device Publish Date: 2024-07-27

On-Brand Devices [PASS LP PASS TL]

• 03613720295631: HOOK B22110008 TP 0-8
• 03613720295624: SET SCREW B22110001 FOR HOOK
• 03613720295747: HOOK B22120008 PEDICLE 0-8
• 03613720295730: HOOK B22120006 PEDICLE 0-6.5
• 03613720295723: HOOK B22120005 PEDICLE 0-5
• 03613720295716: HOOK B22111510R RIGHT TP 15-10
• 03613720295709: HOOK B22111510L LEFT TP 15-10
• 03613720295693: HOOK B22111509R RIGHT TP 15-9
• 03613720295686: HOOK B22111509L LEFT TP 15-9
• 03613720295679: HOOK B22111508R RIGHT TP 15-8
• 03613720295662: HOOK B22111508L LEFT TP 15-8
• 03613720295655: HOOK B22110010 TP 0-10
• 03613720295648: HOOK B22110009 TP 0-9