GUDID 00643169449152

EXT 3708660 DBS NEW BOOT US SYM MRI

MEDTRONIC, INC.

Deep brain electrical stimulation system

• Primary Device ID: 00643169449152
• NIH Device Record Key: 94da7390-561e-40c1-b446-9e4ff41b670f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 3708660
• 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: 60 Centimeter
• Length: 60 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169449152 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P960009

FDA Product Code

• MHY: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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.

• 00763000963705 - NA: 2024-08-05 CUSTOM PACK BB11W58R3 BAP SOUTH E C
• 00763000964061 - NA: 2024-08-05 CUSTOM PACK BB12H45R ST BERNARDS SU
• 20763000963723 - NA: 2024-08-02 CUSTOM PACK 12F80R1 10PK 3/8 PLUG
• 00763000963736 - NA: 2024-08-02 CUSTOM PACK CB5D50R5 3/8 A-V
• 20763000963754 - NA: 2024-08-02 CUSTOM PACK 12H75R 10PK GUARDIA TUBING G
• 00763000963781 - NA: 2024-08-02 CUSTOM PACK BB7L12R8 ADULT E
• 00763000926465 - Hancock™ 150: 2024-07-30 HANCOCK VALVED CONDUIT MO 12MM
• 00763000926472 - Hancock™ 150: 2024-07-30 HANCOCK VALVED CONDUIT MO 14MM