Catalog Number

-

Brand Name

Premium UNIFY PGA Sutures

Version/Model Number

PSG-418R13

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

K022664,K073614,K161629,K200392,K022664,K073614,K161629,K200392,K022664,K073614,K161629,K200392

Product Code

GAM

Product Code Name

Suture, Absorbable, Synthetic, Polyglycolic Acid

Public Device Record Key

18060952-e0ca-4c85-9ffa-48cfa9a4491d

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

August 04, 2020

Package DI Number

20814639024955

Quantity per Package

100

Contains DI Package

10814639024958

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case