Catalog Number

G0022478

Brand Name

Monosyn

Version/Model Number

G0022478

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 24, 2018

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

GAM

Product Code Name

SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Public Device Record Key

5e76502d-f646-4276-916d-1f3759e9905e

Public Version Date

February 05, 2021

Public Version Number

7

DI Record Publish Date

November 11, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-