GUDID 00763000927547

COMM HANDSET TH90Q01 ISTIM X A13 EMAN US

MEDTRONIC, INC.

Multiple active implantable device programmer

• Primary Device ID: 00763000927547
• NIH Device Record Key: 4c8eda5e-476e-4b73-bb25-32f0eb0248de
• 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
• 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	00763000927547 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P080025

FDA Product Code

• EZW: Stimulator, electrical, implantable, for 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: 2024-06-11
• Device Publish Date: 2024-06-03

Devices Manufactured by MEDTRONIC, INC.

• 00763000989903 - NA: 2024-12-30 CUSTOM PACK BB12H87R2 3/8 E PACK
• 00763000989729 - NA: 2024-12-27 CUSTOM PACK BB8S01R5 CITRS AVL
• 20763000989754 - NA: 2024-12-27 CUSTOM PACK BB12G31R2 4PK ENOE CPL
• 20763000989846 - NA: 2024-12-27 CUSTOM PACK BB11L70R1 4PK CP 2013
• 00763000708917 - DiamondTemp™ FASTR RF Generator: 2024-12-23 GENERATOR CEDTG200 FASTR RF US
• 00763000709051 - DiamondTemp™ Irrigation Pump: 2024-12-23 IRRIGATION PUMP CEDTP100 US
• 00763000989156 - NA: 2024-12-23 CUSTOM PACK BB11C49R9 1/4 PACK
• 00763000989163 - NA: 2024-12-23 CUSTOM PACK BB12M25R1 TAPER BOOT