Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

35-403415

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

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

83be97a3-75bd-40cb-a06b-0b304f9a28b2

Public Version Date

June 07, 2019

Public Version Number

3

DI Record Publish Date

September 12, 2016

Package DI Number

50749756609611

Quantity per Package

100

Contains DI Package

00749756609616

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case