Catalog Number

MSG000

Brand Name

MesireTM Guide - Sinus Guide Catheter

Version/Model Number

MSG000

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

K172737

Product Code

LRC

Product Code Name

Instrument, Ent Manual Surgical

Public Device Record Key

2b83c500-ec3c-41c5-a740-cde68c1287fa

Public Version Date

October 05, 2018

Public Version Number

3

DI Record Publish Date

May 30, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-