Catalog Number

-

Brand Name

SeQure

Version/Model Number

SQ28_LB_130

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

K173430

Product Code

DQO

Product Code Name

Catheter, Intravascular, Diagnostic

Public Device Record Key

f799cd77-55b1-4165-8d02-42e9f73bddf6

Public Version Date

December 28, 2020

Public Version Number

4

DI Record Publish Date

August 10, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-