Catalog Number

-

Brand Name

MONO Q

Version/Model Number

Q513C

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

e1d736df-b41c-4c86-8513-81836915c247

Public Version Date

October 17, 2022

Public Version Number

3

DI Record Publish Date

September 18, 2020

Package DI Number

10810020084921

Quantity per Package

12

Contains DI Package

00810020084924

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-