Prodigy Twist™ TWIST5F

GUDID 08500320790008

5F Prodigy Twist™, 177 cm

Truvic Medical, Inc.

Thrombectomy suction catheter
Primary Device ID08500320790008
NIH Device Record Key2b7f764b-8ecf-4679-9fbc-c246a9191e7e
Commercial Distribution StatusIn Commercial Distribution
Brand NameProdigy Twist™
Version Model NumberTWIST5F
Catalog NumberTWIST5F
Company DUNS104006631
Company NameTruvic Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com
Phone1-833-878-8422
Emailcustomerservice@truvic.com

Device Dimensions

Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter
Length177 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS108500320790008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QEWPeripheral Mechanical Thrombectomy With Aspiration

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-26
Device Publish Date2022-04-18

On-Brand Devices [Prodigy Twist™]

085003207900398F Short Prodigy Twist™, 67 cm
085003207900228F Prodigy Twist™, 107 cm
085003207900156F Prodigy Twist™, 154 cm
085003207900085F Prodigy Twist™, 177 cm
008500320790378F Short Prodigy Twist™, 67 cm
008500320790208F Prodigy Twist™, 107 cm
008500320790136F Prodigy Twist™, 154 cm
008500320790065F Prodigy Twist™, 177 cm
008500320791508F Prodigy Twist™, 134cm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.