Prodigy Twist™ TWIST8F-S

GUDID 08500320790039

8F Short Prodigy Twist™, 67 cm

Truvic Medical, Inc.

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