Catalog Number

C0024516

Brand Name

Monoplus

Version/Model Number

C0024516

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

-

Product Code

NEW

Product Code Name

SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Public Device Record Key

5f71c412-ccaa-49dd-97b4-c3230045de2e

Public Version Date

March 26, 2021

Public Version Number

8

DI Record Publish Date

November 11, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-