Catalog Number

-

Brand Name

IMCO

Version/Model Number

J494-IMC

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"

Yes

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

GAM

Product Code Name

Suture, Absorbable, Synthetic, Polyglycolic Acid

Public Device Record Key

ccb455d7-d0f6-467a-b4e8-8d8ad2b19576

Public Version Date

December 10, 2018

Public Version Number

4

DI Record Publish Date

June 13, 2016

Package DI Number

10815842021604

Quantity per Package

12

Contains DI Package

00815842021607

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box