Catalog Number

-

Brand Name

SMART SYRINGE

Version/Model Number

R-RRS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K171698

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Public Device Record Key

e9d6d9cc-3478-464c-9007-96c11bec94fa

Public Version Date

October 30, 2019

Public Version Number

4

DI Record Publish Date

July 11, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-