Catalog Number

-

Brand Name

MONO-DOX

Version/Model Number

M304

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

K013274,K013274

Product Code

NEW

Product Code Name

Suture, Surgical, Absorbable, Polydioxanone

Public Device Record Key

7d6d38cb-3f9f-4aa7-800f-90fb62ec584c

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

July 26, 2016

Package DI Number

20790986001019

Quantity per Package

12

Contains DI Package

10790986001012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-