ACTIVA® SC

GUDID 00613994761088

INS 37603 ACTIVA SC NON PARYLENE US

MEDTRONIC, INC.

Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system

• Primary Device ID: 00613994761088
• NIH Device Record Key: deef4004-587c-4702-a56e-f7a0f2dbd0f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACTIVA® SC
• 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
• 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 -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994761088 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P960009

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: 2017-03-03

On-Brand Devices [ACTIVA® SC]

• 00613994761088: INS 37603 ACTIVA SC NON PARYLENE US
• 00613994761064: INS 37602 ACTIVA SC NON PARYLENE US
• 00643169864214: INS 37603 ACTIVA SC NO PARYLN EMN DBSALP
• 00643169864207: INS 37602 ACTIVA SC NO PARYLN EMN DBSALP
• 00763000100353: INS 37603 ACTIVA SC DBS EMAN
• 00763000100346: INS 37602 ACTIVA SC DBS EMAN
• 00763000384340: INS 37603 ACTIVA SC DBS EMANUAL EN
• 00763000384333: INS 37602 ACTIVA SC DBS EMANUAL EN
• 00763000519230: INS 37603 ACTIVA SC DBS EMANUAL EN
• 00763000519223: INS 37602 ACTIVA SC DBS EMANUAL EN