Catalog Number

-

Brand Name

SILK

Version/Model Number

S683

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)

-

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

42f011fe-8644-4f8d-8aeb-249e2bf337c3

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

October 16, 2015

Package DI Number

10812444021834

Quantity per Package

12

Contains DI Package

00812444021837

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-