Valve, StrataMR II, Regular

GUDID 00763000422653

ASSY 46965MR SHUNT STRATAMR II REG CE

MEDTRONIC PS MEDICAL, INC.

Cerebrospinal fluid shunt valve

• Primary Device ID: 00763000422653
• NIH Device Record Key: 6e2af8cc-6793-49ab-8984-693a5bad3758
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Valve, StrataMR II, Regular
• Version Model Number: 46965MR
• Company DUNS: 089055867
• Company Name: MEDTRONIC PS MEDICAL, 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000422653 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212641

FDA Product Code

• JXG: Shunt, central nervous system and components

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: 2025-01-31
• Device Publish Date: 2025-01-23

Devices Manufactured by MEDTRONIC PS MEDICAL, INC.

• 00763000422653 - Valve, StrataMR II, Regular: 2025-01-31ASSY 46965MR SHUNT STRATAMR II REG CE
• 00763000422653 - Valve, StrataMR II, Regular: 2025-01-31 ASSY 46965MR SHUNT STRATAMR II REG CE
• 00763000422677 - Snap Shunt Assembly, StrataMR II, Regular: 2025-01-31 SHUNT 46966MR SNP ASSY STRATAMRII REG CE
• 00763000422691 - Unassembled Shunt Kit, StrataMR II, Regular: 2025-01-31 KIT 46967MR UNASSY SHNT SMR II REG CE
• 00763000422738 - StrataMR II: 2025-01-15 ASSY 46965MR SHUNT STRATAMR II REGULAR
• 00763000422752 - StrataMR II: 2025-01-15 SHUNT 46966MR SNP ASSY STRATAMR II REG
• 00763000422776 - StrataMR II: 2025-01-15 KIT 46967MR UNASSY SHNT STRATAMR II REG
• 00763000333461 - Exacta™: 2024-12-23 EDMS 27579 EXACTA W/ PATIENT LINE Y-PORT
• 00763000333478 - Exacta™: 2024-12-23 KIT 27581 EXACTA W/EDM VCATH 35CM