Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

77-530045

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

-

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

OEQ

Product Code Name

Angiography/angioplasty kit

Public Device Record Key

98a98fd4-50c7-4af8-8b97-f5d3d7fea208

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 20, 2018

Package DI Number

50749756169191

Quantity per Package

25

Contains DI Package

00749756169196

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case