Socrates

GUDID 00818075010790

Socrates Aspiration System: aspiration tubing set

SCIENTIA VASCULAR LLC

Thrombectomy suction catheter

• Primary Device ID: 00818075010790
• NIH Device Record Key: 6221dfce-7ff2-46dc-ab10-2ae980e7825c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Socrates
• Version Model Number: TS-254-110
• 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

• Length: 254 Centimeter
• Length: 100 Inch
• Length: 254 Centimeter
• Length: 100 Inch
• Length: 254 Centimeter
• Length: 100 Inch
• Length: 254 Centimeter
• Length: 100 Inch
• Length: 254 Centimeter
• Length: 100 Inch
• Length: 254 Centimeter
• Length: 100 Inch
• Length: 254 Centimeter
• Length: 100 Inch
• Length: 254 Centimeter
• Length: 100 Inch
• Length: 254 Centimeter
• Length: 100 Inch
• Length: 254 Centimeter
• Length: 100 Inch
• Length: 254 Centimeter
• Length: 100 Inch
• Length: 254 Centimeter
• Length: 100 Inch
• Length: 254 Centimeter
• Length: 100 Inch
• Length: 254 Centimeter
• Length: 100 Inch
• Length: 254 Centimeter
• Length: 100 Inch
• Length: 254 Centimeter
• Length: 100 Inch
• Length: 254 Centimeter
• Length: 100 Inch

Operating and Storage Conditions

• 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
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818075010790 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223913

FDA Product Code

• NRY: Catheter, Thrombus Retriever

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: 2023-11-22
• Device Publish Date: 2023-11-14

On-Brand Devices [Socrates]

• 00818075011025: Socrates Aspiration System: 127cm working length aspiration catheter
• 00818075010790: Socrates Aspiration System: aspiration tubing set
• 00818075010776: Socrates Aspiration System: 156cm working length aspiration catheter