Prodigy™ Catheter PRODIGY8F

GUDID 00850032079143

8F Prodigy™ Catheter Length: 117 cm Inner Diameter: 2.2 mm Outer Diameter: 2.8 mm

Truvic Medical, Inc.

Thrombectomy suction catheter

• Primary Device ID: 00850032079143
• NIH Device Record Key: 1cd20394-5fa3-4b63-ad73-41dda866d8dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prodigy™ Catheter
• Version Model Number: PRODIGY8F
• Catalog Number: PRODIGY8F
• Company DUNS: 104006631
• Company Name: Truvic 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: 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
• 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
• 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
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com
• Phone: 1-833-878-8422
• Email: customerservice@imperativecare.com

Device Dimensions

• Catheter Length: 117 Centimeter
• Catheter Inner Diameter: 2.2 Millimeter
• Outer Diameter: 2.8 Millimeter
• Catheter Length: 117 Centimeter
• Catheter Inner Diameter: 2.2 Millimeter
• Outer Diameter: 2.8 Millimeter
• Catheter Length: 117 Centimeter
• Catheter Inner Diameter: 2.2 Millimeter
• Outer Diameter: 2.8 Millimeter
• Catheter Length: 117 Centimeter
• Catheter Inner Diameter: 2.2 Millimeter
• Outer Diameter: 2.8 Millimeter
• Catheter Length: 117 Centimeter
• Catheter Inner Diameter: 2.2 Millimeter
• Outer Diameter: 2.8 Millimeter
• Catheter Length: 117 Centimeter
• Catheter Inner Diameter: 2.2 Millimeter
• Outer Diameter: 2.8 Millimeter
• Catheter Length: 117 Centimeter
• Catheter Inner Diameter: 2.2 Millimeter
• Outer Diameter: 2.8 Millimeter
• Catheter Length: 117 Centimeter
• Catheter Inner Diameter: 2.2 Millimeter
• Outer Diameter: 2.8 Millimeter
• Catheter Length: 117 Centimeter
• Catheter Inner Diameter: 2.2 Millimeter
• Outer Diameter: 2.8 Millimeter
• Catheter Length: 117 Centimeter
• Catheter Inner Diameter: 2.2 Millimeter
• Outer Diameter: 2.8 Millimeter
• Catheter Length: 117 Centimeter
• Catheter Inner Diameter: 2.2 Millimeter
• Outer Diameter: 2.8 Millimeter
• Catheter Length: 117 Centimeter
• Catheter Inner Diameter: 2.2 Millimeter
• Outer Diameter: 2.8 Millimeter
• Catheter Length: 117 Centimeter
• Catheter Inner Diameter: 2.2 Millimeter
• Outer Diameter: 2.8 Millimeter
• Catheter Length: 117 Centimeter
• Catheter Inner Diameter: 2.2 Millimeter
• Outer Diameter: 2.8 Millimeter
• Catheter Length: 117 Centimeter
• Catheter Inner Diameter: 2.2 Millimeter
• Outer Diameter: 2.8 Millimeter
• Catheter Length: 117 Centimeter
• Catheter Inner Diameter: 2.2 Millimeter
• Outer Diameter: 2.8 Millimeter
• Catheter Length: 117 Centimeter
• Catheter Inner Diameter: 2.2 Millimeter
• Outer Diameter: 2.8 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter
• Introducer Sheath Compatibilit: 8 French
• Catheter Length: 117 Centimeter

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
• 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
• 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
• 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	00850032079143 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K214114

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: 2023-08-01
• Device Publish Date: 2023-07-24

On-Brand Devices [Prodigy™ Catheter]

• 08500320790077: 8F Short Prodigy™ Catheter Length: 50 cm Inner Diameter: 0.088 in Outer Diameter: 0.110 in (2.
• 08500320790060: 8F Prodigy™ Catheter Length: 90 cm Inner Diameter: 0.088 in Outer Diameter: 0.110 in (2.80 mm)
• 08500320790053: 6F Prodigy™ Catheter Length: 137 cm Inner Diameter: 0.071 in Outer Diameter: 0.085 in (2.13 mm
• 08500320790046: 5F Prodigy™ Catheter Length: 160 cm Inner Diameter: 0.055 in Outer Diameter: 0.067 in (1.70 mm
• 00850032079075: 8F Short Prodigy™ Catheter Length: 50 cm Inner Diameter: 0.088 in Outer Diameter: 0.110 in (2.
• 00850032079068: 8F Prodigy™ Catheter Length: 90 cm Inner Diameter: 0.088 in Outer Diameter: 0.110 in (2.80 mm)
• 00850032079051: 6F Prodigy™ Catheter Length: 137 cm Inner Diameter: 0.071 in Outer Diameter: 0.085 in (2.13 m
• 00850032079044: 5F Prodigy™ Catheter Length: 160 cm Inner Diameter: 0.055 in Outer Diameter: 0.067 in (1.70 m
• 00850032079143: 8F Prodigy™ Catheter Length: 117 cm Inner Diameter: 2.2 mm Outer Diameter: 2.8 mm