SenSight™

GUDID 00763000426491

EXT B3400095 SENSIGHT NO MKR EMAN LJ53

MEDTRONIC, INC.

Deep brain electrical stimulation system

• Primary Device ID: 00763000426491
• NIH Device Record Key: c9f2642d-a3e7-4eb9-8cac-88ae03c280e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SenSight™
• Version Model Number: B3400095
• 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
• 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: 95 Centimeter
• Length: 95 Centimeter
• Length: 95 Centimeter
• Length: 95 Centimeter
• Length: 95 Centimeter
• Length: 95 Centimeter
• Length: 95 Centimeter
• Length: 95 Centimeter
• Length: 95 Centimeter
• Length: 95 Centimeter
• Length: 95 Centimeter
• Length: 95 Centimeter
• Length: 95 Centimeter
• Length: 95 Centimeter
• Length: 95 Centimeter
• Length: 95 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000426491 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H020007

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-14
• Device Publish Date: 2021-06-05

On-Brand Devices [SenSight™]

• 00763000426576: ACCY B31061 CONNECTOR PLUG EMAN LJ53
• 00763000426569: ACCY B31050 EXT TEST CABLE KIT EMAN LJ53
• 00763000426552: ACCY B31040 LEAD TEST CABLE KIT EMN LJ53
• 00763000426545: ACCY B31020 LEAD CAP TORQ WRNCH KIT LJ53
• 00763000426538: ACCY B31010 DPTH STP CRNL TN KT EMN LJ53
• 00763000426521: ACCY B32000 BURR HOLE DEV KIT EMAN LJ53
• 00763000426514: ACCY B31000 BURR HOLE DEV ACCY KIT LJ53
• 00763000426507: EXT B3400095M SENSIGHT W/MKR EMAN LJ53
• 00763000426491: EXT B3400095 SENSIGHT NO MKR EMAN LJ53
• 00763000426484: EXT B3400060M SENSIGHT W/MKR EMAN LJ53
• 00763000426477: EXT B3400060 SENSIGHT NO MKR EMAN LJ53
• 00763000426460: EXT B3400040M SENSIGHT W/MKR EMAN LJ53
• 00763000426453: EXT B3400040 SENSIGHT NO MKR EMAN LJ53
• 00763000426446: LEAD B3301542M SENSIGHT 1.5MM EMAN LJ53
• 00763000426439: LEAD B3301542 SENSIGHT 1.5MM EMAN LJ53
• 00763000426422: LEAD B3301533M SENSIGHT 1.5MM EMAN LJ53
• 00763000426415: LEAD B3301533 SENSIGHT 1.5MM EMAN LJ53
• 00763000426408: LEAD B3300542M SENSIGHT 0.5MM EMAN LJ53
• 00763000426392: LEAD B3300542 SENSIGHT 0.5MM EMAN LJ53
• 00763000426385: LEAD B3300533M SENSIGHT 0.5MM EMAN LJ53
• 00763000426378: LEAD B3300533 SENSIGHT 0.5MM EMAN LJ53
• 00763000426361: ACCY B31030 EXT TNLR DBS EMAN LJ53
• 00763000451868: ACCY B31030 EXT TNLR DBS PAPER LJ55