Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

35-530007

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

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

07fd6aaf-17b7-4df4-bd0f-ecd5c4b807d4

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

September 12, 2016

Package DI Number

50749756653867

Quantity per Package

50

Contains DI Package

00749756653862

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case