Catalog Number

-

Brand Name

Exofin Fusion Skin Closure System, 6cm

Version/Model Number

EF70406

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

6acdbe61-1b26-4082-8294-d2a6c82ed099

Public Version Date

May 23, 2022

Public Version Number

1

DI Record Publish Date

May 13, 2022

Package DI Number

00854137001610

Quantity per Package

6

Contains DI Package

00854137001603

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Sleeve