Accurian

GUDID 00763000835637

PROBE KIT ACCURIAN SU SS 50MM 16-22G

MEDTRONIC SOFAMOR DANEK, INC.

Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar

• Primary Device ID: 00763000835637
• NIH Device Record Key: a35fc116-22e0-4c3f-8b77-11501cc4ee87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accurian
• Version Model Number: APSD050
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 4
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store between -20°C and 50°C
• Special Storage Condition, Specify: Between 0 and 0 *Store between -20°C and 50°C
• Special Storage Condition, Specify: Between 0 and 0 *Store between -20°C and 50°C
• Special Storage Condition, Specify: Between 0 and 0 *Store between -20°C and 50°C
• Special Storage Condition, Specify: Between 0 and 0 *Store between -20°C and 50°C
• Special Storage Condition, Specify: Between 0 and 0 *Store between -20°C and 50°C
• Special Storage Condition, Specify: Between 0 and 0 *Store between -20°C and 50°C
• Special Storage Condition, Specify: Between 0 and 0 *Store between -20°C and 50°C
• Special Storage Condition, Specify: Between 0 and 0 *Store between -20°C and 50°C
• Special Storage Condition, Specify: Between 0 and 0 *Store between -20°C and 50°C
• Special Storage Condition, Specify: Between 0 and 0 *Store between -20°C and 50°C
• Special Storage Condition, Specify: Between 0 and 0 *Store between -20°C and 50°C
• Special Storage Condition, Specify: Between 0 and 0 *Store between -20°C and 50°C
• Special Storage Condition, Specify: Between 0 and 0 *Store between -20°C and 50°C
• Special Storage Condition, Specify: Between 0 and 0 *Store between -20°C and 50°C
• Special Storage Condition, Specify: Between 0 and 0 *Store between -20°C and 50°C
• Special Storage Condition, Specify: Between 0 and 0 *Store between -20°C and 50°C

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000835637 [Unit of Use]
GS1	20763000835631 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181864

FDA Product Code

• GXI: Probe, radiofrequency lesion

Sterilization

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

[00763000835637]

Ethylene Oxide

[00763000835637]

Ethylene Oxide

[00763000835637]

Ethylene Oxide

[00763000835637]

Ethylene Oxide

[00763000835637]

Ethylene Oxide

[00763000835637]

Ethylene Oxide

[00763000835637]

Ethylene Oxide

[00763000835637]

Ethylene Oxide

[00763000835637]

Ethylene Oxide

[00763000835637]

Ethylene Oxide

[00763000835637]

Ethylene Oxide

[00763000835637]

Ethylene Oxide

[00763000835637]

Ethylene Oxide

[00763000835637]

Ethylene Oxide

[00763000835637]

Ethylene Oxide

[00763000835637]

Ethylene Oxide

[00763000835637]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-03
• Device Publish Date: 2023-09-25

On-Brand Devices [Accurian]

• 00763000140830: HUB APH200 ENHANCED CONNECTOR
• 00763000140823: HUB APH100 STANDARD CONNECTOR
• 00763000140816: PUMP AP1000 PUMP W/STAND
• 00763000140809: GENERATOR AG1000 RF GENERATOR W/STAND
• 20763000153698: CANNULA AC0020 100MM 22G 10MM CB
• 20763000153681: CANNULA AC0018 100MM 22G 10MM CS
• 20763000153674: CANNULA AC0016 100MM 22G 5MM CS
• 20763000153667: CANNULA AC0019 100MM 22G 10MM SS
• 20763000153650: CANNULA AC0017 100MM 22G 5MM SS
• 20763000153643: CANNULA AC0015 50MM 22G 5MM CS
• 20763000153636: CANNULA AC0014 150MM 20G 10MM CB
• 20763000153629: CANNULA AC0012 150MM 20G 10MM CS
• 20763000153612: CANNULA AC0013 150MM 20G 10MM SS
• 20763000153605: CANNULA AC0011 100MM 20G 10MM CB
• 20763000153599: CANNULA AC0009 100MM 20G 10MM CS
• 20763000153582: CANNULA AC0010 100MM 20G 10MM SS
• 20763000153575: CANNULA AC0008 50MM 20G 10MM CS
• 20763000153568: CANNULA AC0007 150MM 18G 10MM CS
• 20763000153551: CANNULA AC0005 100MM 18G 10MM CS
• 20763000153544: CANNULA AC0006 100MM 18G 10MM SS
• 20763000153537: CANNULA AC0004 50MM 18G 10MM CS
• 20763000153520: CANNULA AC0003 150MM 16G 10MM CS
• 20763000153513: CANNULA AC0002 100MM 16G 10MM CS
• 20763000153506: CANNULA AC0001 50MM 16G 10MM CS
• 00763000155247: PROBE APSN150 REUSE NITINL 150MM 16G-22G
• 00763000155230: PROBE APSN100 REUSE NITINL 100MM 16G-22G
• 00763000155223: PROBE APSN050 REUSE NITINOL 50MM 16G-22G
• 00763000155216: PROBE APSR150 REUSABLE SS 150MM 16-22G
• 00763000155209: PROBE APSR100 REUSABLE SS 100MM 16-22G
• 00763000155193: PROBE APSR050 REUSABLE SS 50MM 16-22G
• 00763000153496: PROBE APSC06 150MM 12MM ENHANCED
• 00763000153489: PROBE APSC05 100MM 12MM ENHANCED
• 00763000153472: PROBE APSC04 50MM 12MM ENHANCED
• 00763000153465: PROBE APSC03 150MM 10MM ENHANCED
• 00763000153458: PROBE APSC02 100MM 10 MM ENHANCED
• 00763000153441: PROBE APSC01 50MM 10MM ENHANCED
• 00763000153427: PROBE APSD150 SINGLE USE SS 150MM 16-22G
• 00763000153410: PROBE APSD100 SINGLE USE SS 100MM 16-22G
• 00763000153403: PROBE APSD050 SINGLE USE SS 50MM 16-22G
• 00763000171216: PUMP ASP001 REFURBISHED
• 00763000171209: GENERATOR ASG001 REFURBISHED
• 00763000710187: INTRODCR AI0009 100MM 7MM-2MM TIP ENHNCD
• 00763000710170: INTRODCR AI0007 50MM 7MM-2MM TIP ENHNCD
• 00763000710163: PROBE APSC09 100MM 7MM-2MM TIP ENHANCED
• 00763000710156: PROBE APSC07 50MM 7MM-2MM TIP ENHANCED
• 20763000715568: ACCURIANTM PROBE METAL TUBING150MM
• 20763000715551: ACCURIANTM PROBE METAL TUBING100MM
• 20763000715544: ACCURIANTM PROBE METAL TUBING50MM
• 00763000835651: PROBE KIT ACCURIAN SU SS 150MM 16-22G
• 00763000835644: PROBE KIT ACCURIAN SU SS 100MM 16-22G