Catalog Number

800099B

Brand Name

LF

Version/Model Number

100104-A

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

83572c28-f4c4-4d0c-91ef-325db101d32f

Public Version Date

March 15, 2021

Public Version Number

1

DI Record Publish Date

March 05, 2021

Package DI Number

26938327906010

Quantity per Package

50

Contains DI Package

06938327906016

Package Discontinue Date

December 31, 9999

Package Status

In Commercial Distribution

Package Type

carton