Catalog Number

-

Brand Name

Sofsilk

Version/Model Number

GS46M-2

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

K981128,K981128

Product Code

GAP

Product Code Name

SUTURE, NONABSORBABLE, SILK

Public Device Record Key

08c2422e-6607-43d7-825a-3231a2ceaab5

Public Version Date

May 03, 2022

Public Version Number

3

DI Record Publish Date

January 29, 2020

Package DI Number

20884521758015

Quantity per Package

24

Contains DI Package

10884521758018

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE