Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

77-401012

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"

Yes

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

-

Product Code

DXT

Product Code Name

INJECTOR AND SYRINGE, ANGIOGRAPHIC

Public Device Record Key

3cdc67e6-4515-49e1-a9a9-033e3c325996

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 12, 2016

Package DI Number

50749756826025

Quantity per Package

25

Contains DI Package

00749756826020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case