Catalog Number

-

Brand Name

Silk Sutures

Version/Model Number

9143

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

K080684,K080684,K080684

Product Code

GAP

Product Code Name

Suture, Nonabsorbable, Silk

Public Device Record Key

55eaceca-bf98-4e06-8a79-20c25fc964ba

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

00616784914336

Quantity per Package

25

Contains DI Package

00616784914329

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-