Catalog Number

-

Brand Name

WEGO-PGA Absorbable Surgical Suture With Needle

Version/Model Number

G1004503

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

6031443c-ad97-40d2-9f4e-2cc7ebe5714d

Public Version Date

September 09, 2021

Public Version Number

4

DI Record Publish Date

November 24, 2015

Package DI Number

6941813690016

Quantity per Package

12

Contains DI Package

06941813600015

Package Discontinue Date

September 01, 2021

Package Status

Not in Commercial Distribution

Package Type

-