Catalog Number

EF70401

Brand Name

Exofin Fusion Skin Closure System

Version/Model Number

22cm

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

K171442,K171442

Product Code

OMD

Product Code Name

Cutaneous Tissue Adhesive With Mesh

Public Device Record Key

dca894a2-eaf8-43d3-81dd-c118fbf44182

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 25, 2017

Package DI Number

10854137001235

Quantity per Package

2

Contains DI Package

00854137001238

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-