Catalog Number

C0024717

Brand Name

Monoplus

Version/Model Number

C0024717

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 13, 2021

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

401c935a-5c07-48c8-bf74-5c804aeae307

Public Version Date

April 12, 2021

Public Version Number

10

DI Record Publish Date

August 06, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-