Catalog Number

003-0043

Brand Name

ACE Surgical Ch Gut 3-0 27" Ds18

Version/Model Number

ZG-0043N

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GAM

Product Code Name

SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Public Device Record Key

643b79f5-f699-4ad0-b9df-967d476983d3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 22, 2015

Package DI Number

10848782023100

Quantity per Package

12

Contains DI Package

00848782023103

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box