Catalog Number

017354

Brand Name

FastLoad™ CTA Dual Syringe Pack

Version/Model Number

017354

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

K933846,K933846

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Public Device Record Key

32b856e4-e426-49bf-b5a9-db10e7c44c54

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

October 20, 2017

Package DI Number

37630039300884

Quantity per Package

20

Contains DI Package

17630039300880

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box