Catalog Number

-

Brand Name

UNIFY Silk Surgical Sutures

Version/Model Number

XXL-S330K60

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

K000541,K080684,K000541,K080684,K000541,K080684

Product Code

GAP

Product Code Name

Suture, Nonabsorbable, Silk

Public Device Record Key

a8c51b45-4d29-45eb-894b-d5f0b884d61a

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

January 01, 2017

Package DI Number

20814639023132

Quantity per Package

100

Contains DI Package

10814639023135

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case