Catalog Number

-

Brand Name

WEGO-PGCL Absorbable Surgical Suture With Needle

Version/Model Number

Q36243

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

6b0cd187-9a87-4188-b942-a1f44d7e5483

Public Version Date

September 27, 2021

Public Version Number

4

DI Record Publish Date

April 18, 2016

Package DI Number

06941813635512

Quantity per Package

12

Contains DI Package

06941813630517

Package Discontinue Date

September 01, 2021

Package Status

Not in Commercial Distribution

Package Type

-