Catalog Number

-

Brand Name

Exofin XL

Version/Model Number

EX72006

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

K152476,K152476

Product Code

MPN

Product Code Name

Tissue Adhesive For The Topical Approximation Of Skin

Public Device Record Key

3caaa203-d34e-4cb8-88f8-7b76bf225cef

Public Version Date

June 07, 2019

Public Version Number

1

DI Record Publish Date

May 30, 2019

Package DI Number

00854137001481

Quantity per Package

6

Contains DI Package

00854137001474

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box