Catalog Number

833S-IMC

Brand Name

Silk

Version/Model Number

833S-IMC

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

-

Product Code

GAP

Product Code Name

Suture, Nonabsorbable, Silk

Public Device Record Key

4fbc5797-b335-499a-84c6-d02a31545885

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

August 03, 2017

Package DI Number

20790986006854

Quantity per Package

12

Contains DI Package

10790986007014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-