Catalog Number

-

Brand Name

Disposable High Pressure Syringe

Version/Model Number

SMR301

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

K170279,K170279

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Public Device Record Key

25e3e3be-621f-4690-8afa-9d8c88552fd4

Public Version Date

November 26, 2020

Public Version Number

2

DI Record Publish Date

December 26, 2018

Package DI Number

56970286900099

Quantity per Package

50

Contains DI Package

06970286900094

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-