PASS LP PASS TULIP

GUDID 03613720294955

PLATE B02250060L SACROILAC PLATE RIGHT

MEDICREA INTERNATIONAL

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 03613720294955
• NIH Device Record Key: 9897fc49-b0c2-452e-afe2-bf5cb46f754e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PASS LP PASS TULIP
• Version Model Number: B02250060L
• 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	03613720294955 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182240

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[03613720294955]

Moist Heat or Steam Sterilization

[03613720294955]

Moist Heat or Steam Sterilization

[03613720294955]

Moist Heat or Steam Sterilization

[03613720294955]

Moist Heat or Steam Sterilization

[03613720294955]

Moist Heat or Steam Sterilization

[03613720294955]

Moist Heat or Steam Sterilization

[03613720294955]

Moist Heat or Steam Sterilization

[03613720294955]

Moist Heat or Steam Sterilization

[03613720294955]

Moist Heat or Steam Sterilization

[03613720294955]

Moist Heat or Steam Sterilization

[03613720294955]

Moist Heat or Steam Sterilization

[03613720294955]

Moist Heat or Steam Sterilization

[03613720294955]

Moist Heat or Steam Sterilization

[03613720294955]

Moist Heat or Steam Sterilization

[03613720294955]

Moist Heat or Steam Sterilization

[03613720294955]

Moist Heat or Steam Sterilization

[03613720294955]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-01
• Device Publish Date: 2024-07-24

On-Brand Devices [PASS LP PASS TULIP]

• 03613720295617: CONNECTOR B22066212 OP/OP DOMINO 12MM
• 03613720294962: PLATE B02250060R SACROILAC PLATE LEFT
• 03613720294955: PLATE B02250060L SACROILAC PLATE RIGHT