Activa® SC

GUDID 00643169864214

INS 37603 ACTIVA SC NO PARYLN EMN DBSALP

MEDTRONIC, INC.

Deep brain electrical stimulation system

• Primary Device ID: 00643169864214
• NIH Device Record Key: 4f475d80-75bd-4706-b6bd-a14efeef8f36
• 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: MR Conditional
• 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 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169864214 [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: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-24

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
• 00763000924614: INS 37602 ACTIVA SC DBS EMANUAL EN US
• 00763000924621: INS 37603 ACTIVA SC DBS EMANUAL EN US