StrataVarius®

GUDID 00643169373686

KIT 45806 STRATA VARIUS

MEDTRONIC PS MEDICAL, INC.

Cerebrospinal fluid shunt valve programmer

• Primary Device ID: 00643169373686
• NIH Device Record Key: 5a739a9e-3ff4-41b3-a635-06c8dcb7bff6
• 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: Labeling does not contain MRI Safety Information
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169373686 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-07-16

On-Brand Devices [StrataVarius®]

• 00643169373686: KIT 45806 STRATA VARIUS
• 00885074467795: TOOL 45809 STRATAVARIUS ADJUSTMENT
• 00763000351410: CARD 45807 SMART STRATA
• 00763000292546: KIT 45806 STRATA VARIUS