Catalog Number

89-10124

Brand Name

DeRoyal

Version/Model Number

89-10124

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

OEQ

Product Code Name

Angiography/angioplasty kit

Public Device Record Key

78d560c4-2171-4e6c-bdf8-5ce2e72ed9c7

Public Version Date

May 17, 2021

Public Version Number

1

DI Record Publish Date

May 07, 2021

Package DI Number

50749756980406

Quantity per Package

3

Contains DI Package

00749756980401

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case