Catalog Number

-

Brand Name

UNIFY Chromic Gut Surgical Sutures

Version/Model Number

S-C418R13

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)

Yes

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

GAR

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyamide

Public Device Record Key

fc11b993-bac5-4c2c-8572-57053996595d

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

August 21, 2015

Package DI Number

10814639021292

Quantity per Package

12

Contains DI Package

00814639021295

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box