Activa®

GUDID 00613994761071

INS 37603 ACTIVA SC INLINE EXT US

MEDTRONIC, INC.

Deep brain electrical stimulation system

• Primary Device ID: 00613994761071
• NIH Device Record Key: 3429d5ee-824a-4340-b67e-27b108c86537
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Activa®
• Version Model Number: 37603
• 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: true
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994761071 [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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-23

On-Brand Devices [Activa®]

• 00613994934611: INS 37612 ACTIVA RC eMANUAL
• 00613994761071: INS 37603 ACTIVA SC INLINE EXT US
• 00613994761057: INS 37602 ACTIVA SC DUAL PIN EXT US