Catalog Number

-

Brand Name

DemeSILK

Version/Model Number

SK16600,9F4P

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

K023029,K023029

Product Code

GAP

Product Code Name

Suture, Nonabsorbable, Silk

Public Device Record Key

06921b2c-bb9e-4ab4-81e4-64e825c62196

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

June 19, 2019

Package DI Number

30652927307741

Quantity per Package

12

Contains DI Package

10652927307747

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-