Catalog Number

-

Brand Name

Rempress

Version/Model Number

100

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

-

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

K092896,K092896

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Public Device Record Key

0e06183f-281b-4003-bd61-6af1579f3fc8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 15, 2016

Package DI Number

14560138481001

Quantity per Package

1

Contains DI Package

04560138481004

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton