BRYAN® Cervical Disc System

GUDID 00613994363626

TRIAL 6474056 SIZER 16MM

MEDTRONIC SOFAMOR DANEK, INC.

Spinal implant trial

• Primary Device ID: 00613994363626
• NIH Device Record Key: bb090c59-3987-4c80-bdc5-8eab37716dbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BRYAN® Cervical Disc System
• Version Model Number: 6474056
• 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: 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

Device Dimensions

• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994363626 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P060023

FDA Product Code

• MJO: PROSTHESIS, INTERVERTEBRAL DISC

Sterilization

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

[00613994363626]

Moist Heat or Steam Sterilization

[00613994363626]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2014-09-23

On-Brand Devices [BRYAN® Cervical Disc System]

• 00613994365354: DISC 6478418 MILLING 18MM
• 00613994365347: DISC 6478417 MILLING 17MM
• 00613994365330: DISC 6478416 MILLING 16MM
• 00613994365323: DISC 6478415 MILLING 15MM
• 00613994365316: DISC 6478414 MILLING 14MM
• 00613994363824: CUTTER 6474524 14MM
• 00613994363817: CUTTER 6474525 15MM
• 00613994363800: CUTTER 6474526 16MM
• 00613994363794: CUTTER 6474527 17MM
• 00613994363787: CUTTER 6474528 18MM
• 00613994363640: TRIAL 6474058 SIZER 18MM
• 00613994363633: TRIAL 6474057 SIZER 17MM
• 00613994363626: TRIAL 6474056 SIZER 16MM
• 00613994363619: TRIAL 6474055 SIZER 15MM
• 00613994363602: TRIAL 6474054 SIZER 14MM
• 00613994360717: INSERTER 6473610 IMPLANT
• 00613994181244: MOTION 6470318 18MM BRYAN CRV DSC PRSTHS
• 00613994181237: MOTION 6470317 17MM BRYAN CRV DSC PRSTHS
• 00613994181220: MOTION 6470316 16MM BRYAN CRV DSC PRSTHS
• 00613994181213: MOTION 6470315 15MM BRYAN CRV DSC PRSTHS
• 00613994181206: MOTION 6470314 14MM BRYAN CRV DSC PRSTHS