Catalog Number

G0024004

Brand Name

Monoplus

Version/Model Number

G0024004

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 15, 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

020767fe-542b-4a67-baeb-6abae293265b

Public Version Date

February 05, 2021

Public Version Number

8

DI Record Publish Date

November 12, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-