Activa® RC

GUDID 00643169105492

IPG 37612 PKG ACTIVA RC DBS US MED-REL

MEDTRONIC, INC.

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• Primary Device ID: 00643169105492
• NIH Device Record Key: c4dfbea9-fd60-4afe-85b5-ecf41610ac36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Activa® RC
• Version Model Number: 37612
• 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 -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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169105492 [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: 2017-08-05

On-Brand Devices [Activa® RC]

• 00643169105492: IPG 37612 PKG ACTIVA RC DBS US MED-REL
• 00643169864238: INS 37612 ACTIVA RC NO PRYLN EMN DBS ALP
• 00643169613713: INS 37612 ACTIVA RC NON-PARAYLENE EMAN
• 00763000100360: INS 37612 ACTIVA RC DBS EMAN
• 00763000384357: INS 37612 ACTIVA RC DBS EMANUAL EN
• 00763000519247: INS 37612 ACTIVA RC DBS EMANUAL EN