Catalog Number

-

Brand Name

WEGO-SILK Non-absorbable Surgical Suture With Needle

Version/Model Number

S44183

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

GAP

Product Code Name

Suture, Nonabsorbable, Silk

Public Device Record Key

cd432ae6-4f99-4000-adcb-81b3e49c55bf

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

September 28, 2015

Package DI Number

06941813657729

Quantity per Package

12

Contains DI Package

06941813652724

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-