Catalog Number

128-400101

Brand Name

Genus

Version/Model Number

100111-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

K151960,K151960

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Public Device Record Key

d36af09f-4cc9-4443-b0a5-4b4913c8638c

Public Version Date

January 21, 2022

Public Version Number

1

DI Record Publish Date

January 13, 2022

Package DI Number

26938327904641

Quantity per Package

50

Contains DI Package

06938327904647

Package Discontinue Date

December 31, 9999

Package Status

In Commercial Distribution

Package Type

carton