IB3D™ PL Spinal System

GUDID 00763000883492

TRAY A24100100 IB3D PL TRAY

MEDTRONIC SOFAMOR DANEK, INC.

Instrument tray, reusable

• Primary Device ID: 00763000883492
• NIH Device Record Key: c2217b45-478f-4f8b-8b09-5bad2f97db48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IB3D™ PL Spinal System
• Version Model Number: A24100100
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• 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: false
• 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(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	00763000883492 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190840

FDA Product Code

• KCT: Sterilization wrap containers, trays, cassettes & other accessories

Sterilization

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

[00763000883492]

Moist Heat or Steam Sterilization

[00763000883492]

Moist Heat or Steam Sterilization

[00763000883492]

Moist Heat or Steam Sterilization

[00763000883492]

Moist Heat or Steam Sterilization

[00763000883492]

Moist Heat or Steam Sterilization

[00763000883492]

Moist Heat or Steam Sterilization

[00763000883492]

Moist Heat or Steam Sterilization

[00763000883492]

Moist Heat or Steam Sterilization

[00763000883492]

Moist Heat or Steam Sterilization

[00763000883492]

Moist Heat or Steam Sterilization

[00763000883492]

Moist Heat or Steam Sterilization

[00763000883492]

Moist Heat or Steam Sterilization

[00763000883492]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-08
• Device Publish Date: 2025-03-31

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

• 00763000679675 - POWEREASE™ Instruments: 2025-08-05 SLEEVE 2342402 LOCKING MPA SLEEVE
• 00763000679682 - POWEREASE™ Instruments: 2025-08-05 SLEEVE 2343435 15MM SLEEVE
• 00763000671525 - VERTE-STACK Spinal System: 2025-08-04 INSERTER 6246011 HANDLE OUTER
• 00763000674458 - Medtronic Resuable Instruments: 2025-08-04 FREEHAND HOLDER 9877701 LORDOTIC 3-HOLE
• 00763000679415 - Medtronic Resuable Instruments: 2025-08-04 GUIDE 9874133 DBL BARREL 0 DEG
• 00763000679460 - Medtronic Resuable Instruments: 2025-08-04 HOLDER 9870001 4HOLE PLATE FREE HAND
• 00763000679538 - Medtronic Resuable Instruments: 2025-08-04 PLATE HOLDER 9874640 4 HOLE
• 00763000679545 - Medtronic Resuable Instruments: 2025-08-04 HOLDER 9874145 STAND ALONE