GUDID 00763000825997

COMM HANDSET TH90Q01 ISTIM X EMAN US

MEDTRONIC, INC.

Multiple active implantable device programmer

• Primary Device ID: 00763000825997
• NIH Device Record Key: ef5bae3e-30c8-4c3d-9a89-7f27ae63b0f6
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: TH90Q01
• 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: true
• Device Combination Product: false
• Single Use: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000825997 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P080025

FDA Product Code

• QON: Implanted electrical device intended for treatment of fecal incontinence

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-17
• Device Publish Date: 2023-04-07

Devices Manufactured by MEDTRONIC, INC.

• 00763000959616 - AEX: 2025-04-04 AEX GENERATOR 40-405-1R REFURB US
• 20763000651736 - Aortic Punch: 2025-03-31 Aortic Punch APU425 - 2.5mm punch size
• 20763000651743 - Aortic Punch: 2025-03-31 Aortic Punch APU430 - 3.0mm punch size
• 20763000651750 - Aortic Punch: 2025-03-31 Aortic Punch APU435 - 3.5mm punch size
• 20763000651767 - Aortic Punch: 2025-03-31 Aortic Punch APU440 - 4.0mm punch size
• 20763000651774 - Aortic Punch: 2025-03-31 Aortic Punch APU444 - 4.4mm punch size
• 20763000651781 - Aortic Punch: 2025-03-31 Aortic Punch APU448 - 4.8mm punch size
• 20763000651798 - Aortic Punch: 2025-03-31 Aortic Punch APU450 - 5.0mm punch size