DBS

GUDID 00643169516571

LEAD 3389S-40 DBS STMLOC .5MM ACTVA EMAN

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: 00643169516571
• NIH Device Record Key: 2f6a2bbe-4095-4f97-9cdb-f0ba96330dab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DBS
• Version Model Number: 3389S-40
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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

Device Dimensions

• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169516571 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P960009

FDA Product Code

• NHL: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2015-02-11

On-Brand Devices [DBS]

• 00643169516786: LEAD 3391S-40 DBS HDE EMAN NO SCRNR CBL
• 00643169516571: LEAD 3389S-40 DBS STMLOC .5MM ACTVA EMAN
• 00643169516557: LEAD 3389S-28 DBS STMLOC .5MM ACTVA EMAN
• 00643169516540: LEAD 3387S-40 DBS STMLOC ACTIVA LBL UPDT