Catalog Number

-

Brand Name

MONO Q

Version/Model Number

Q967

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

-

Product Code

GAM

Product Code Name

Suture, Absorbable, Synthetic, Polyglycolic Acid

Public Device Record Key

02a9c3e2-3f03-4833-bcdb-1f3b3faa59bb

Public Version Date

October 17, 2022

Public Version Number

4

DI Record Publish Date

October 16, 2015

Package DI Number

10812444021322

Quantity per Package

12

Contains DI Package

00812444021325

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-