Catalog Number

-

Brand Name

Sofsilk

Version/Model Number

XX-5239

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

45330780-81fd-405f-bea0-7452260b8cfc

Public Version Date

May 03, 2022

Public Version Number

8

DI Record Publish Date

September 03, 2015

Package DI Number

20884521105888

Quantity per Package

12

Contains DI Package

10884521105881

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE