MEDTRONIC® DBS™

GUDID 00643169858985

LIT 3337L DYSTONIA 37603 W/3387S DBS ALP

MEDTRONIC, INC.

Deep brain electrical stimulation system

• Primary Device ID: 00643169858985
• NIH Device Record Key: 8a6ec820-e931-4562-89e2-a93f49306243
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDTRONIC® DBS™
• Version Model Number: 3337L
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169858985 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H020007

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-07-30

On-Brand Devices [MEDTRONIC® DBS™]

• 00643169141766: LIT 3339L DYSTONIA 37603 W/3389S NEW EXT
• 00643169141759: LIT 3337L DYSTONIA 37603 W/3387S NEW EXT
• 00643169141742: LIT 3319L DYSTONIA 37601 W/3389S NEW EXT
• 00643169141735: LIT 3317L DYSTONIA 37601 W/3387S NEW EXT
• 00643169091153: LIT 3330L DYSTONIA 37603
• 00643169091146: LIT 3320L DYSTONIA 37602 INS
• 00643169091115: LIT 3310L DYSTONIA 37601 INS
• 00643169858992: LIT 3339L DYSTONIA 37603 W/3389S DBS ALP
• 00643169858985: LIT 3337L DYSTONIA 37603 W/3387S DBS ALP
• 00643169858978: LIT 3330L DYSTONIA 37603 DBS ALP
• 00643169858961: LIT 3320L DYSTONIA 37602 DBS ALP
• 00643169858954: LIT 3319L DYSTONIA 37601 W/3389S DBS ALP
• 00643169858947: LIT 3317L DYSTONIA 37601 W/3387S DBS ALP
• 00643169858930: LIT 3310L DYSTONIA 37601 DBS ALP
• 00763000007638: LIT 3339L DYSTONIA 37603 W/3389S DBS
• 00763000007621: LIT 3337L DYSTONIA 37603 W/3387S DBS
• 00763000007614: LIT 3330L DYSTONIA 37603 DBS
• 00763000007607: LIT 3320L DYSTONIA 37602 DBS
• 00763000007591: LIT 3319L DYSTONIA 37601 W/3389S DBS
• 00763000007584: LIT 3317L DYSTONIA 37601 W/3387S DBS
• 00763000007577: LIT 3310L DYSTONIA 37601 DBS