Catalog Number

-

Brand Name

WEGO-SILK Non-absorbable Surgical Suture With Needle

Version/Model Number

SB3603

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"

-

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

GAP

Product Code Name

Suture, Nonabsorbable, Silk

Public Device Record Key

14be1592-0927-4aa1-a9da-a5c63d401afd

Public Version Date

September 29, 2021

Public Version Number

5

DI Record Publish Date

September 28, 2015

Package DI Number

06941813658665

Quantity per Package

12

Contains DI Package

06941813653660

Package Discontinue Date

September 01, 2021

Package Status

Not in Commercial Distribution

Package Type

-