GUDID 00763000278762

ENS 97725 WIRELESS INTELLIS US EMAN

MEDTRONIC, INC.

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, external

• Primary Device ID: 00763000278762
• NIH Device Record Key: 6f8c5895-d699-4468-89d0-e876b082b9b3
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 97725
• 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
• 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
• 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

• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 54 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000278762 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-15
• Device Publish Date: 2021-02-06

Devices Manufactured by MEDTRONIC, INC.

• 20763000558332 - HR HTC: 2026-03-03 CARTRIDGE 402-07 HR HTC BXD 20BX
• 00199150003709 - Sphere-9™ Catheter: 2026-03-02 CATHETER AFR-00001 SPHERE 9 US GAL
• 20763000558189 - CLOTtrac™: 2026-03-02 CONTROL 550-01 CLOTTRAC CWB
• 20763000558196 - CLOTtrac™: 2026-03-02 CONTROL 550-07 CLOTTRAC HR 15BX
• 20763000558202 - CLOTtrac™: 2026-03-02 CONT 550-08 CLOTTRAC HR ABN BXD ASY
• 20763000558219 - CLOTtrac™: 2026-03-02 CONT 550-09 CLOTTRAC LR ABN BXD ASY
• 20763000558226 - CLOTtrac™: 2026-03-02 CONT 550-10 CLOTTRAC RACT ABN
• 20763000558233 - CLOTtrac™: 2026-03-02 CONTROL 550-12 CLOTTRAC HTC