Catalog Number

-

Brand Name

LF

Version/Model Number

844010

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

-

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Public Device Record Key

512e0870-04c5-4d00-bab1-94ea7c681a24

Public Version Date

January 05, 2022

Public Version Number

4

DI Record Publish Date

September 09, 2016

Package DI Number

20746190002243

Quantity per Package

50

Contains DI Package

10746190002246

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case