Percept™ PC BrainSense™

GUDID 00763000420987

INS B35200 PERCEPT PC DBS EMAN EN

MEDTRONIC, INC.

Deep brain electrical stimulation system

• Primary Device ID: 00763000420987
• NIH Device Record Key: ec57a28f-85d7-4e5a-acb2-d11336bffcda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Percept™ PC BrainSense™
• Version Model Number: B35200
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00763000420987 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H020007

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-30
• Device Publish Date: 2020-11-22

On-Brand Devices [Percept™ PC BrainSense™]

• 00763000253363: INS B35200 DBS PERCEPT PC US EMAN
• 00763000420987: INS B35200 PERCEPT PC DBS EMAN EN
• 00763000519216: INS B35200 DBS PERCEPT PC EMANUAL EN
• 00763000916268: INS B35200 PERCEPT PC DBS EMANUAL US EN