Catalog Number

-

Brand Name

PRESS DUO elite

Version/Model Number

260

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

-

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

K173450,K173450

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Public Device Record Key

17453abb-1186-4766-9475-c2f338ddb549

Public Version Date

September 06, 2018

Public Version Number

1

DI Record Publish Date

August 06, 2018

Package DI Number

14560138482602

Quantity per Package

1

Contains DI Package

04560138482605

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-