Catalog Number

-

Brand Name

Regard™

Version/Model Number

AN01041F

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OKE

Product Code Name

Port Introducer Kit

Public Device Record Key

c3eeec98-6e91-4782-b531-c2c106818343

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

March 03, 2020

Package DI Number

20194717107245

Quantity per Package

4

Contains DI Package

10194717107248

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-