Activa® PC

GUDID 00643169100770

IPG 37601 ACTIVA PC DBS LA UPDATED HYBRI

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: 00643169100770
• NIH Device Record Key: 9bf707d6-fcdf-47ee-9e1d-d98990c02066
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Activa® PC
• Version Model Number: 37601
• 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 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
• 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	00643169100770 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P960009

FDA Product Code

• OLM: Deep brain stimulator for obsessive compulsive disorder (OCD)

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: 2016-05-08

On-Brand Devices [Activa® PC]

• 00613994934604: IPG 37601 ACTIVA PC Emanual
• 00643169100770: IPG 37601 ACTIVA PC DBS LA UPDATED HYBRI
• 00643169864191: INS 37601 ACTIVA PC NO PARYLN EMN DBSALP
• 00763000175719: INS 37601 ACTIVA PC EMAN EPILEPSY
• 00763000310332: INS 37601 ACTIVA PC DBS EMANUAL EN
• 00763000384326: INS 37601 ACTIVA PC DBS EMANUAL EN