Aristotle Z14-200-004

GUDID 00818075010240

Guidewire 200cm Extra Support

SCIENTIA VASCULAR LLC

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 00818075010240
• NIH Device Record Key: 5e9de4f6-8537-42ea-b4f0-0f55031f6211
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aristotle
• Version Model Number: 14-200-004
• Catalog Number: Z14-200-004
• Company DUNS: 011234178
• Company Name: SCIENTIA VASCULAR LLC
• 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com
• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com
• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com
• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com
• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com
• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com
• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com
• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com
• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com
• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com
• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com
• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com
• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com
• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com
• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com
• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com
• Phone: 888.385.9016
• Email: regulatory@scientiavascular.com

Device Dimensions

• Guidewire Length: 200 Centimeter
• Guidewire Diameter: 0.014 Inch
• Guidewire Length: 200 Centimeter
• Guidewire Diameter: 0.014 Inch
• Guidewire Length: 200 Centimeter
• Guidewire Diameter: 0.014 Inch
• Guidewire Length: 200 Centimeter
• Guidewire Diameter: 0.014 Inch
• Guidewire Length: 200 Centimeter
• Guidewire Diameter: 0.014 Inch
• Guidewire Length: 200 Centimeter
• Guidewire Diameter: 0.014 Inch
• Guidewire Length: 200 Centimeter
• Guidewire Diameter: 0.014 Inch
• Guidewire Length: 200 Centimeter
• Guidewire Diameter: 0.014 Inch
• Guidewire Length: 200 Centimeter
• Guidewire Diameter: 0.014 Inch
• Guidewire Length: 200 Centimeter
• Guidewire Diameter: 0.014 Inch
• Guidewire Length: 200 Centimeter
• Guidewire Diameter: 0.014 Inch
• Guidewire Length: 200 Centimeter
• Guidewire Diameter: 0.014 Inch
• Guidewire Length: 200 Centimeter
• Guidewire Diameter: 0.014 Inch
• Guidewire Length: 200 Centimeter
• Guidewire Diameter: 0.014 Inch
• Guidewire Length: 200 Centimeter
• Guidewire Diameter: 0.014 Inch
• Guidewire Length: 200 Centimeter
• Guidewire Diameter: 0.014 Inch
• Guidewire Length: 200 Centimeter
• Guidewire Diameter: 0.014 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818075010240 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201760

FDA Product Code

• MOF: Guide, Wire, Catheter, Neurovasculature

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: 2023-10-03
• Device Publish Date: 2023-09-25

On-Brand Devices [Aristotle]

• 00818075010110: Guidewire-Support
• 00818075010103: Guidewire-Standard
• 00818075010097: Guidewire-Soft
• 00818075010035: Guidewire- Support
• 00818075010028: Guidewire - Soft
• 00818075010011: Guidewire- Support
• 00818075010004: Guidewire-Soft
• 00818075010141: Guidewire-Support
• 00818075010134: Guidewire-Standard
• 00818075010127: Guidewire-Soft
• 00818075010691: Guidewire - Standard
• 00818075011018: Guidewire - Standard
• 00818075010264: Guidewire 300cm Extra Support
• 00818075010257: Guidewire 300cm Support
• 00818075010240: Guidewire 200cm Extra Support
• 00818075010233: Guidewire 200cm Support
• 00818075011193: Guidewire - Support
• 00818075011186: Guidewire - Standard
• 00818075011179: Guidewire - Soft