GUDID 00763000875718

COMMUNICATOR 8880T2-RFB CLN CTM REFRB US

MEDTRONIC, INC.

Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer

• Primary Device ID: 00763000875718
• NIH Device Record Key: 4cb9ef31-0c73-45dc-a45e-2f10255ebc93
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 8880T2-RFB
• 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: 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
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -35 Degrees Celsius and 58 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000875718 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H020007

FDA Product Code

• MRU: implanted subcortical electrical Stimulator (motor disorders)

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: 2023-11-24
• Device Publish Date: 2023-11-16

Devices Manufactured by MEDTRONIC, INC.

• 20763000770291 - TrailBlazer™: 2024-07-16 PS ASC-014-090 TRAILBLAZER ANGLED V04
• 20763000770307 - TrailBlazer™: 2024-07-16 PS ASC-014-135 TRAILBLAZER ANGLED V04
• 20763000770314 - TrailBlazer™: 2024-07-16 PS ASC-014-150 TRAILBLAZER ANGLED V04
• 20763000770321 - TrailBlazer™: 2024-07-16 PS ASC-018-090 TRAILBLAZER ANGLED V04
• 20763000770338 - TrailBlazer™: 2024-07-16 PS ASC-018-135 TRAILBLAZER ANGLED V04
• 20763000770345 - TrailBlazer™: 2024-07-16 PS ASC-018-150 TRAILBLAZER ANGLED V04
• 20763000770352 - TrailBlazer™: 2024-07-16 PS ASC-035-065 TRAILBLAZER ANGLED V04
• 20763000770369 - TrailBlazer™: 2024-07-16 PS ASC-035-090 TRAILBLAZER ANGLED V04