Surpass Elite FDSE40020

GUDID 07613327582796

Flow Diverter System

Stryker Corporation

Bare-metal intracranial vascular stent

• Primary Device ID: 07613327582796
• NIH Device Record Key: 0849f07f-e65e-45ff-9e72-e7a5928a2e4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surpass Elite
• Version Model Number: FDSE40020
• Catalog Number: FDSE40020
• Company DUNS: 042405446
• Company Name: Stryker Corporation
• 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: true
• 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(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com

Device Dimensions

• Length: 20 Millimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 20 Millimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 20 Millimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 20 Millimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 20 Millimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 20 Millimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 20 Millimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 20 Millimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 20 Millimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 20 Millimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 20 Millimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 20 Millimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 20 Millimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 20 Millimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 20 Millimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 20 Millimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 20 Millimeter
• Lumen/Inner Diameter: 4 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327582796 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P170024

FDA Product Code

• OUT: Intracranial aneurysm flow diverter

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: 2024-07-24
• Device Publish Date: 2024-07-16

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• 07613327582680: Flow Diverter System
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