DBS™ Reclaim®

GUDID 00643169864283

LEAD 3391S-40 NO OR CBL MRI COND EMN ALP

MEDTRONIC, INC.

Deep brain electrical stimulation system

• Primary Device ID: 00643169864283
• NIH Device Record Key: 4d1df324-b561-446a-8f90-4d35a0343de1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DBS™ Reclaim®
• Version Model Number: 3391S-40
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169864283 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H050003

FDA Product Code

• OLM: Deep brain stimulator for obsessive compulsive disorder (OCD)

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: 2018-02-24

Devices Manufactured by MEDTRONIC, INC.

• 00199150068180 - NA: 2026-02-02 CUSTOM PACK BB12H59R3 HLN UCHICAGCP
• 00199150068210 - NA: 2026-02-02 CUSTOM PACK BB8Y34R13 LOWVOLPED
• 20199150068238 - NA: 2026-02-02 CUSTOM PACK BB12S73R1 20PK ACC 3LF
• 20199150068290 - NA: 2026-02-02 CUSTOM PACK 12T24R 5PK ACC CARDIO
• 20199150068405 - NA: 2026-02-02 CUSTOM PACK BB12R56R3 4PK CPN DEL NI
• 00199150061679 - NA: 2026-01-29 CUSTOM PACK BB12S73R HLN 3LF
• 20613994654063 - DLP®: 2026-01-29 PCP SET 50011 5FR - 14GA 10PK 17L
• 00199150027521 - Cardioblate™: 2026-01-26 CLAMP 49321 CARDIOBLATE BP2 FT