Accurian™

GUDID 00763000405014

SFTWR KIT AGSW001 ACCURIAN GENRTR 1.1

MEDTRONIC SOFAMOR DANEK, INC.

Multiple active implantable device programmer

• Primary Device ID: 00763000405014
• NIH Device Record Key: c2b02b96-309b-4d37-aa50-7bd906050f16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accurian™
• Version Model Number: AGSW001
• 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
• 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	00763000405014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181864

FDA Product Code

• GXD: Generator, lesion, radiofrequency

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-05
• Device Publish Date: 2020-09-27

On-Brand Devices [Accurian™]

• 00763000312268: INTRODUCER AI0006 150MM 12MM ENHANCED
• 00763000312251: INTRODUCER AI0005 100MM 12MM ENHANCED
• 00763000312244: INTRODUCER AI0004 50MM 12MM ENHANCED
• 00763000312220: INTRODUCER AI0002 100MM 10MM ENHANCED
• 00763000312213: INTRODUCER AI0001 50MM 10MM ENHANCED
• 00763000312237: INTRODUCER AI0003 150MM 10MM ENHANCED
• 00763000405014: SFTWR KIT AGSW001 ACCURIAN GENRTR 1.1