DBS™

GUDID 00643169752283

LEAD 3389S-28 EMAN SCNR CBL RMV MR CDTNL

MEDTRONIC, INC.

Deep brain electrical stimulation system Deep brain electrical stimulation system

• Primary Device ID: 00643169752283
• NIH Device Record Key: 9370c039-bcc7-448f-b050-7ff9b36abee4
• 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: MR Conditional
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169752283 [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: 2017-11-25

On-Brand Devices [DBS™]

• 00613994844668: ACCY 3755 TUNNELING TOOL DBS US
• 00613994749161: EXTENSION 748351 DBS NO TUNNEL TOOL US
• 00613994749123: EXTENSION 3708695 DBS NO TUNNEL TOOL US
• 00613994749116: EXTENSION 3708660 DBS NO TUNNEL TOOL US
• 00613994749109: EXTENSION 3708640 DBS NO TUNNEL TOOL US
• 00613994981363: LEAD 3389S-40 DBS ACTIVA STMLC LCAP EMAN
• 00613994981356: LEAD 3389S-28 DBS ACTIVA STMLC LCAP EMAN
• 00643169752290: LEAD 3387S-40 EMAN SCNR CBL RMV MR CDTNL
• 00643169752283: LEAD 3389S-28 EMAN SCNR CBL RMV MR CDTNL
• 00643169752276: LEAD 3389S-40 EMAN SCNR CBL RMV MR CDTNL
• 00763000306687: ACCY KIT 3755 DBS TUNNELING TOOL 40CM
• 00763000274412: LEAD KIT 3391S-40 DBS STMLC RECLAIM EMAN
• 00763000274405: LEAD KIT 3389S-40 DBS STMLOC ACTIVA EMAN
• 00763000274399: LEAD KIT 3389S-28 DBS STMLOC ACTIVA EMAN
• 00763000274320: LEAD KIT 3387S-40 DBS STMLOC ACTIVA EMAN