Catalog Number

77-3041

Brand Name

DeRoyal

Version/Model Number

77-3041

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

e8696c19-c874-4086-9fc5-37aa6ab42ead

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 17, 2016

Package DI Number

50749756800179

Quantity per Package

100

Contains DI Package

00749756800174

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CORRUGATE CASE