Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

32-1485

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

DXZ

Product Code Name

PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Public Device Record Key

7c40996d-f593-42f7-8b73-7aedf0cfffd8

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

September 12, 2016

Package DI Number

50749756252411

Quantity per Package

12

Contains DI Package

00749756252416

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case