Catalog Number

-

Brand Name

WEGO-PDO Absorbable Surgical Suture With Needle

Version/Model Number

D53162

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 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

NEW

Product Code Name

Suture, Surgical, Absorbable, Polydioxanone

Public Device Record Key

da52ee39-2b1f-451e-a903-915fe6fb3339

Public Version Date

July 26, 2021

Public Version Number

7

DI Record Publish Date

April 12, 2016

Package DI Number

06941813616351

Quantity per Package

12

Contains DI Package

06941813611356

Package Discontinue Date

June 01, 2021

Package Status

Not in Commercial Distribution

Package Type

-