ACCURIAN™

GUDID 00763000312251

INTRODUCER AI0005 100MM 12MM ENHANCED

MEDTRONIC SOFAMOR DANEK, INC.

Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system

• Primary Device ID: 00763000312251
• NIH Device Record Key: 77268cf5-9c53-4ca6-90c2-d9b2ac374216
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCURIAN™
• Version Model Number: AI0005
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 10
• DM Exempt: true
• 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

Device Dimensions

• Length: 100 Millimeter
• Needle Gauge: 17 Gauge
• Length: 100 Millimeter
• Needle Gauge: 17 Gauge
• Length: 100 Millimeter
• Needle Gauge: 17 Gauge
• Length: 100 Millimeter
• Needle Gauge: 17 Gauge
• Length: 100 Millimeter
• Needle Gauge: 17 Gauge
• Length: 100 Millimeter
• Needle Gauge: 17 Gauge
• Length: 100 Millimeter
• Needle Gauge: 17 Gauge
• Length: 100 Millimeter
• Needle Gauge: 17 Gauge
• Length: 100 Millimeter
• Needle Gauge: 17 Gauge
• Length: 100 Millimeter
• Needle Gauge: 17 Gauge
• Length: 100 Millimeter
• Needle Gauge: 17 Gauge
• Length: 100 Millimeter
• Needle Gauge: 17 Gauge
• Length: 100 Millimeter
• Needle Gauge: 17 Gauge
• Length: 100 Millimeter
• Needle Gauge: 17 Gauge
• Length: 100 Millimeter
• Needle Gauge: 17 Gauge

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000312251 [Unit of Use]
GS1	20763000312255 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181864

FDA Product Code

• GEI: Electrosurgical, cutting & coagulation & accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-08
• Device Publish Date: 2020-05-31

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