Catalog Number

-

Brand Name

Disposable High Pressure Injector Syringe

Version/Model Number

100100C/10060A

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

K152906

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Public Device Record Key

b5d3be50-8e8a-435f-9994-26a51167ec37

Public Version Date

February 08, 2021

Public Version Number

1

DI Record Publish Date

January 31, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-