Catalog Number

SYM-IS-003

Brand Name

Regulus Introducer Set with Hemostatic Valve

Version/Model Number

SYM-IS-003

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"

-

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

K140917

Product Code

DYB

Product Code Name

Introducer, Catheter

Public Device Record Key

8ac53443-1e65-4388-91d3-fa5e8420063d

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

November 30, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-