Catalog Number

-

Brand Name

WEGO-Polyester Nonabsorbable Surgical Suture With Needle

Version/Model Number

E53222D

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"

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

K080684,K080684

Product Code

GAT

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyethylene

Public Device Record Key

edc86782-23de-46b5-a6ff-28f1f1e8e64f

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

April 19, 2016

Package DI Number

06941813666264

Quantity per Package

12

Contains DI Package

06941813661269

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-