Catalog Number

-

Brand Name

WEGO-PGA Absorbable Surgical Suture With Needle

Version/Model Number

G13252

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

K073614,K073614

Product Code

GAM

Product Code Name

Suture, Absorbable, Synthetic, Polyglycolic Acid

Public Device Record Key

950b0067-0d63-4e4c-bd50-a6f3264b0eeb

Public Version Date

September 09, 2021

Public Version Number

4

DI Record Publish Date

December 03, 2015

Package DI Number

06941813690504

Quantity per Package

12

Contains DI Package

06941813600503

Package Discontinue Date

September 01, 2021

Package Status

Not in Commercial Distribution

Package Type

-