GUDID 00763000826000

COMM HANDSET TH90QFA ISTIM X EMAN US

MEDTRONIC, INC.

Multiple active implantable device programmer

• Primary Device ID: 00763000826000
• NIH Device Record Key: 244d366f-db68-40d0-bc05-5f2c8e005534
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: TH90QFA
• 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	00763000826000 [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.

• 00763000432973 - Vectris™: 2024-08-12 LEAD 977D160 TRIALING MRICS SBCMPCT EMAN
• 00763000432980 - Vectris™: 2024-08-12 LEAD 977D260 TRIALING MRICS COMPACT EMAN
• 00763000964603 - NA: 2024-08-12 CUSTOM PACK BB12H12R2 ADULT TABLE P
• 20763000967110 - NA: 2024-08-12 CUSTOM PACK BB12H25R 5PK 1/8 IN M/M
• 00763000967451 - NA: 2024-08-12 CUSTOM PACK BB12H59R UCHICAGOCPB3/8
• 00763000967482 - NA: 2024-08-12 CUSTOM PACK BB11M88R16 CARDIOHELP P
• 00763000946395 - DLP®: 2024-08-12 ADAPTER 10001 STRAIGHT 20PK 17L
• 00763000946517 - DLP®: 2024-08-12 CANNULA 70420 ART FLEX ARCH 20FR 20P 17L