Catalog Number

-

Brand Name

DemeSILK

Version/Model Number

SK263016F4P

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

e2750078-2263-4b80-9f67-1769704b1fd5

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

June 19, 2019

Package DI Number

30652927210133

Quantity per Package

12

Contains DI Package

10652927210139

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-