DBS

GUDID 00643169516557

LEAD 3389S-28 DBS STMLOC .5MM ACTVA EMAN

MEDTRONIC, INC.

Deep brain electrical stimulation system

• Primary Device ID: 00643169516557
• NIH Device Record Key: 3d980fa2-71d4-4d73-8dfe-7353398cf585
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DBS
• Version Model Number: 3389S-28
• 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

Device Dimensions

• Length: 28 Centimeter
• Length: 28 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169516557 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P960009

FDA Product Code

• MRU: implanted subcortical electrical Stimulator (motor disorders)

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