GUDID 00643169449169

EXT 3708695 DBS NEW BOOT US SYM MRI

MEDTRONIC, INC.

Deep brain electrical stimulation system

• Primary Device ID: 00643169449169
• NIH Device Record Key: fd2c6f99-8e70-4d78-b26f-c26a663200db
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 3708695
• 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: 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

Device Dimensions

• Length: 95 Centimeter
• Length: 95 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	00643169449169 [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: 2016-09-18

Devices Manufactured by MEDTRONIC, INC.

• 20763000990286 - NA: 2026-03-24 CUSTOM PACK BB12M54R1 10PK 1/4 LINE
• 20763000284897 - OctoBase™: 2026-03-23 INSERTS 28707 RETRACTOR DPSH 10PK 31L
• 00199150071623 - NA: 2026-03-16 CUSTOM PACK BB11X36R2 EVL SUPPORT
• 20199150071917 - NA: 2026-03-16 CUSTOM PACK BB8S03R4 10PK EVL ACCESS
• 00199150071920 - NA: 2026-03-16 CUSTOM PACK BB9G55R9 HLO TVA FU
• 00199150071937 - NA: 2026-03-16 CUSTOM PACK BB10P43R7 TRIDENT A
• 00199150071944 - NA: 2026-03-16 CUSTOM PACK BB12R46R1 EVL TABLE
• 20199150072020 - NA: 2026-03-16 CUSTOM PACK BB12T66R 10PK AVL HALI