Catalog Number

-

Brand Name

UNIFY Nylon Surgical Sutures

Version/Model Number

M-N518R16

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

GAR

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyamide

Public Device Record Key

1d948ade-e29a-4017-b428-af4773ed01fc

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

November 09, 2016

Package DI Number

20814639022616

Quantity per Package

100

Contains DI Package

10814639022619

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case