StrataMR

GUDID 00763000422714

VALVE 42965MR STRATAMR II REGULAR

MEDTRONIC PS MEDICAL, INC.

Cerebrospinal fluid shunt valve

• Primary Device ID: 00763000422714
• NIH Device Record Key: 8b8ae640-1cee-40b9-a241-4fa9a568bd47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StrataMR
• Version Model Number: 42965MR
• 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
• 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	00763000422714 [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: 2022-09-02
• Device Publish Date: 2022-08-25

On-Brand Devices [StrataMR]

• 00643169616486: UNISHUNT 46985 FP STRATAMR REG 13.5 VENT
• 00643169616479: UNISHUNT 46975 FP STRATAMR SM 11.5 VENT
• 00643169616462: SHUNT 46970 SNAP STRATAMR REG
• 00643169616455: SHUNT 46960 SNAP STRATAMR SMALL
• 00643169593442: ASSY 46955 FP SHUNT STRATAMR SMALL
• 00643169593435: ASSY 46965 FP SHUNT STRATAMR REGULAR
• 00763000067571: FULL SET 45909SMR STRATAMR ADJUST TOOL
• 00763000422714: VALVE 42965MR STRATAMR II REGULAR
• 00763000422707: VALVE 42955MR STRATAMR II SMALL