Catalog Number

-

Brand Name

LF

Version/Model Number

601280

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

6db7ae24-6e3e-4fce-8cbb-9f26e8addd38

Public Version Date

January 05, 2022

Public Version Number

3

DI Record Publish Date

March 03, 2020

Package DI Number

20746190002083

Quantity per Package

25

Contains DI Package

10746190002086

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case