StrataVarius

GUDID 00763000266974

KIT 45806 STRATA VARIUS

MEDTRONIC PS MEDICAL, INC.

Cerebrospinal fluid shunt valve programmer

• Primary Device ID: 00763000266974
• NIH Device Record Key: d16c5ef0-b755-4a76-9359-78b4737ee260
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StrataVarius
• Version Model Number: 45806
• Company DUNS: 089055867
• Company Name: MEDTRONIC PS MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000266974 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041992

FDA Product Code

• JXG: Shunt, central nervous system and components

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-14
• Device Publish Date: 2020-04-06

On-Brand Devices [StrataVarius]

• 00763000266981: TOOL 45809 STRATAVARIUS ADJUSTMENT
• 00763000266974: KIT 45806 STRATA VARIUS
• 00763000292553: TOOL 45809 STRATAVARIUS ADJUSTMENT