Catalog Number

-

Brand Name

WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle

Version/Model Number

P46163-45

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"

-

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

GAW

Product Code Name

Suture, Nonabsorbable, Synthetic, Polypropylene

Public Device Record Key

6bd6e1ad-efd7-4a0e-8ae5-c9cb503720a1

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

August 25, 2020

Package DI Number

06941813678458

Quantity per Package

12

Contains DI Package

06941813673453

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-