Prodigy Twist™ - 6F Prodigy Twist™, 154 cm - Truvic Medical, Inc.

Duns Number:104006631

Device Description: 6F Prodigy Twist™, 154 cm

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More Product Details

Catalog Number

TWIST6F

Brand Name

Prodigy Twist™

Version/Model Number

TWIST6F

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K214114

Product Code Details

Product Code

QEW

Product Code Name

Peripheral Mechanical Thrombectomy With Aspiration

Device Record Status

Public Device Record Key

44206750-27fd-459e-be12-d7159ab277cc

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

June 27, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TRUVIC MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 18