StrataMR II

GUDID 00763000422738

ASSY 46965MR SHUNT STRATAMR II REGULAR

MEDTRONIC PS MEDICAL, INC.

Cerebrospinal fluid shunt valve

• Primary Device ID: 00763000422738
• NIH Device Record Key: 4a58c6ec-99ba-42a9-98f0-9ce69d00d85e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StrataMR II
• 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
• 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	00763000422738 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-01-15
• Device Publish Date: 2022-12-24

On-Brand Devices [StrataMR II]

• 00763000422639: VALVE 42965MR STRATAMR II REGULAR CE
• 00763000422622: VALVE 42955MR STRATAMR II SMALL CE
• 00763000422776: KIT 46967MR UNASSY SHNT STRATAMR II REG
• 00763000422752: SHUNT 46966MR SNP ASSY STRATAMR II REG
• 00763000422738: ASSY 46965MR SHUNT STRATAMR II REGULAR
• 00763000422660: SHUNT 46956MR SNP ASSY STRATAMRII SM CE