Catalog Number

844021S

Brand Name

LF

Version/Model Number

100104-D

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 31, 9999

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

K182289,K182289

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Public Device Record Key

4e8b94e7-5ae6-4292-8936-e09ea516fce9

Public Version Date

May 11, 2020

Public Version Number

3

DI Record Publish Date

January 18, 2020

Package DI Number

26938327903101

Quantity per Package

50

Contains DI Package

06938327903107

Package Discontinue Date

December 31, 9999

Package Status

In Commercial Distribution

Package Type

CARTON