GUDID 00763000292096

COMM HANDSET KIT TH91D01 DBS US PPR EN

MEDTRONIC, INC.

Multiple active implantable device programmer

• Primary Device ID: 00763000292096
• NIH Device Record Key: cf0b74a4-a4e6-4795-a95f-2ec89637875c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: TH91D01
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000292096 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H020007

FDA Product Code

• MHY: Stimulator, electrical, implanted, for parkinsonian tremor

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: 2020-07-13
• Device Publish Date: 2020-07-05

Devices Manufactured by MEDTRONIC, INC.

• 20763000394091 - DxTerity™: 2025-01-28 DXT6JL45X DXT 6F 5PK 125CM JL45
• 20763000395180 - DxTerity™ TRA: 2025-01-28 CATH U5ULTRA35 DXT 5F 5PK 100CM UL35
• 00763000993924 - NA: 2025-01-28 CUSTOM PACK BB10Y59R12 FUSION
• 00763000993931 - NA: 2025-01-28 CUSTOM PACK BB7M46R26 SCV ADLT
• 00763000993948 - NA: 2025-01-28 CUSTOM PACK BB11U59R5 BYPASS TUBING
• 00763000993955 - NA: 2025-01-28 CUSTOM PACK BB8M65R3 RIDEOUT
• 08033477072012 - Pacific™ Plus: 2025-01-28 CATH PCP060300090 PLUS US D6L300UL900
• 08033477072029 - Pacific™ Plus: 2025-01-28 CATH PCP060300150 PLUS US D6L300UL1500