GUDID 00885074404530

EXTSN 3708260 8-2-4 OCTAPOLAR 60CM AA

MEDTRONIC, INC.

Neural-tissue electrical stimulation lead

• Primary Device ID: 00885074404530
• NIH Device Record Key: d144c933-a858-4804-97ee-cc4109b87a64
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 3708260
• Company DUNS: 796986144
• Company Name: MEDTRONIC, 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: true
• Lot Batch: false
• Serial Number: true
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885074404530 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P840001

FDA Product Code

• LGW: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-23

Devices Manufactured by MEDTRONIC, INC.

• 00763000835392 - HawkOne™: 2025-01-06 ATHERECTOMY H1-14550 CUTTER DRIVER UNI
• 00763000989224 - NA: 2025-01-06 CUSTOM PACK BB12B64R6 GOLD H/L PACK
• 00763000990060 - NA: 2025-01-06 CUSTOM PACK BB12M44R UMCEP SHUNT PK
• 20763000990088 - NA: 2025-01-06 CUSTOM PACK 9D70R2 10PK HDR PK
• 20763000990460 - NA: 2025-01-06 CUSTOM PACK BB12M56R 10PK 1/4 SUPPLEMENT
• 20763000990484 - NA: 2025-01-06 CUSTOM PACK BB12M39R 2PK PACK C STRAIGH
• 20763000990507 - NA: 2025-01-06 CUSTOM PACK 11C82R1 4PK CARDIOPLEG
• 00763000990510 - NA: 2025-01-06 CUSTOM PACK BB11Y33R6 PED SM ADT