StrataMR2

GUDID 00763000422646

ASSY 46955MR SHUNT STRATAMR II SMALL

MEDTRONIC PS MEDICAL, INC.

Ventriculoperitoneal shunt

• Primary Device ID: 00763000422646
• NIH Device Record Key: 25fa16f0-be93-48b7-a788-918b3685f4d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StrataMR2
• Version Model Number: 46955MR
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000422646 [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: 2026-03-23
• Device Publish Date: 2026-03-13

On-Brand Devices [StrataMR2]

• 00763000422684: KIT 46957MR UNASSY SHNT SMR II SM
• 00763000422646: ASSY 46955MR SHUNT STRATAMR II SMALL