PASS SPINAL SYSTEM

GUDID 03613720293828

COVER PLATE B02150005 SACRAL PLATE CAP

MEDICREA INTERNATIONAL

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 03613720293828
• NIH Device Record Key: 8bb28233-8438-4d87-998d-5d56d7708133
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PASS SPINAL SYSTEM
• Version Model Number: B02150005
• 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	03613720293828 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080099

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[03613720293828]

Moist Heat or Steam Sterilization

[03613720293828]

Moist Heat or Steam Sterilization

[03613720293828]

Moist Heat or Steam Sterilization

[03613720293828]

Moist Heat or Steam Sterilization

[03613720293828]

Moist Heat or Steam Sterilization

[03613720293828]

Moist Heat or Steam Sterilization

[03613720293828]

Moist Heat or Steam Sterilization

[03613720293828]

Moist Heat or Steam Sterilization

[03613720293828]

Moist Heat or Steam Sterilization

[03613720293828]

Moist Heat or Steam Sterilization

[03613720293828]

Moist Heat or Steam Sterilization

[03613720293828]

Moist Heat or Steam Sterilization

[03613720293828]

Moist Heat or Steam Sterilization

[03613720293828]

Moist Heat or Steam Sterilization

[03613720293828]

Moist Heat or Steam Sterilization

[03613720293828]

Moist Heat or Steam Sterilization

[03613720293828]

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

Devices Manufactured by MEDICREA INTERNATIONAL

• 03613720293538 - PASS LP: 2024-08-05 CASE A02200558 REVISION MODULE
• 03613720293552 - PASS LP: 2024-08-05 TEMPLATE A02100003 MALLEABLE ROD 150MM
• 03613720293569 - PASS LP: 2024-08-05 TEMPLATE A02100008 MALLEABLE ROD 450MM
• 03613720293576 - PASS LP: 2024-08-05 CADDY A02200557 ILIAC FIXATION PASS LP
• 03613720293583 - PASS LP 2.0: 2024-08-05 FEELER A02310000 PEDICLE FEELER STIFF
• 03613720293590 - PASS LP 2.0: 2024-08-05 AWL A02310020 SQUARED AWL REAMER
• 03613720293606 - PASS LP 2.0: 2024-08-05 PROBE A02310060 PEDICLE CURVED
• 03613720293613 - PASS LP: 2024-08-05 WRENCH A02320002 ROD ROTATING WRENCH