Prodigy Twist™ TWIST8F-S

GUDID 08500320790039

8F Short Prodigy Twist™, 67 cm

Truvic Medical, 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 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 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 Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter

• Primary Device ID: 08500320790039
• NIH Device Record Key: 7d5163ac-7883-4083-9db1-11e5cf03f66e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prodigy Twist™
• Version Model Number: TWIST8F-S
• Catalog Number: TWIST8F-S
• 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@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com
• Phone: 1-833-878-8422
• Email: customerservice@truvic.com

Device Dimensions

• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter
• Length: 67 Centimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08500320790039 [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: 2022-04-26
• Device Publish Date: 2022-04-18

On-Brand Devices [Prodigy Twist™]

• 08500320790039: 8F Short Prodigy Twist™, 67 cm
• 08500320790022: 8F Prodigy Twist™, 107 cm
• 08500320790015: 6F Prodigy Twist™, 154 cm
• 08500320790008: 5F Prodigy Twist™, 177 cm
• 00850032079037: 8F Short Prodigy Twist™, 67 cm
• 00850032079020: 8F Prodigy Twist™, 107 cm
• 00850032079013: 6F Prodigy Twist™, 154 cm
• 00850032079006: 5F Prodigy Twist™, 177 cm
• 00850032079150: 8F Prodigy Twist™, 134cm