Symphony™ Advance™ Long Dilator ADVANCE

GUDID 00850032079174

24F Symphony™ Advance™ Long Dilator

IMPERATIVE CARE, INC.

Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter

• Primary Device ID: 00850032079174
• NIH Device Record Key: b02ddee4-21cd-4978-90f5-c9bb02c3ac5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Symphony™ Advance™ Long Dilator
• Version Model Number: ADVANCE
• Catalog Number: ADVANCE
• Company DUNS: 080816678
• Company Name: IMPERATIVE CARE, 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: 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: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com

Device Dimensions

• Introducer Sheath Compatibilit: 24 French
• Introducer Sheath Compatibilit: 24 French
• Introducer Sheath Compatibilit: 24 French
• Introducer Sheath Compatibilit: 24 French
• Introducer Sheath Compatibilit: 24 French
• Introducer Sheath Compatibilit: 24 French
• Introducer Sheath Compatibilit: 24 French
• Introducer Sheath Compatibilit: 24 French
• Introducer Sheath Compatibilit: 24 French
• Introducer Sheath Compatibilit: 24 French
• Introducer Sheath Compatibilit: 24 French
• Introducer Sheath Compatibilit: 24 French
• Introducer Sheath Compatibilit: 24 French
• Introducer Sheath Compatibilit: 24 French
• Introducer Sheath Compatibilit: 24 French

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850032079174 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223216

FDA Product Code

• QEW: Peripheral Mechanical Thrombectomy With Aspiration

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: 2024-03-12
• Device Publish Date: 2024-03-04

Devices Manufactured by IMPERATIVE CARE, INC.

• 00850032079174 - Symphony™ Advance™ Long Dilator: 2024-03-1224F Symphony™ Advance™ Long Dilator
• 00850032079174 - Symphony™ Advance™ Long Dilator: 2024-03-12 24F Symphony™ Advance™ Long Dilator
• 10850032079164 - Symphony™ Clot Container: 2024-02-12 Symphony Clot Container
• 00812212030573 - ZOOM™ 88 Large Distal Platform™ Support: 2023-06-12 ZOOM™ 88 088 LDP Support, 100 cm
• 00812212030511 - ZOOM™ RDL Radial Access System, 95cm: 2022-10-06 ZOOM™ RDL, 95cm with dilator
• 00812212030528 - ZOOM™ RDL Radial Access System, 105cm: 2022-10-06 ZOOM™ RDL, 105cm with dilator
• 00812212030535 - ZOOM™ RDL Radial Access System, 110cm: 2022-10-06 ZOOM™ RDL, 110cm with dilator
• 00812212030566 - ZOOM™ RDL Radial Access System, 103cm: 2022-10-06 ZOOM™ RDL, 103cm with dilator
• 00812212030399 - TracStar™ Large Distal Platform: 2022-08-19 TracStar™ LDP, 95 cm