Catalog Number

-

Brand Name

WEGO-PGCL Absorbable Surgical Suture With Needle

Version/Model Number

Q63193

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 01, 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"

Yes

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

K142810,K142810

Product Code

GAM

Product Code Name

Suture, Absorbable, Synthetic, Polyglycolic Acid

Public Device Record Key

d926e168-b885-40a2-96d4-f59ff221e9c5

Public Version Date

September 20, 2021

Public Version Number

4

DI Record Publish Date

April 18, 2016

Package DI Number

06941813635840

Quantity per Package

12

Contains DI Package

06941813630845

Package Discontinue Date

September 01, 2021

Package Status

Not in Commercial Distribution

Package Type

-