Catalog Number

TWIST8F

Brand Name

Prodigy Twist™

Version/Model Number

TWIST8F

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

QEW

Product Code Name

Peripheral Mechanical Thrombectomy With Aspiration

Public Device Record Key

46c2f219-8a60-409d-89d5-3718ec430c8a

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

June 27, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-