GUDID 00763000258115

ENS 97725 WIRELESS INTELLIS US EMAN

MEDTRONIC, INC.

Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator

• Primary Device ID: 00763000258115
• NIH Device Record Key: 9b612056-6708-45fe-a96d-bb456250e20f
• 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

Operating and Storage Conditions

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000258115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P840001

FDA Product Code

• QRB: Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-07-31
• Device Publish Date: 2020-06-08

Devices Manufactured by MEDTRONIC, INC.

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• 00763000613624 - Mosaic Ultra™7308U: 2025-03-11 SIZERS 7308U MOSAIC ULTRA AORTIC MDR
• 00763000613631 - Mosaic™7310: 2025-03-11 OBTURATORS 7310 MOSAIC MITRAL MDR
• 00763000613648 - NA: 2025-03-11 HANDLE 7639 VALVE MDR
• 00763000613655 - NA: 2025-03-11 HANDLE 7639XL VALVE XL MDR
• 00763000613662 - NA: 2025-03-11 ACCESSORY 7642 LOCK NUT MDR
• 00763000614034 - Hancock™ II 7505: 2025-03-11 OBTURATOR 7505SET HK II AORTIC MDR
• 00763000614041 - Hancock™ II 7510: 2025-03-11 OBTURATOR 7510SET HK II MITRAL MDR