Catalog Number

-

Brand Name

Exofin

Version/Model Number

M1206

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

K132243,K132243,K132243

Product Code

MPN

Product Code Name

Tissue Adhesive For The Topical Approximation Of Skin

Public Device Record Key

49ad70ff-74c4-4bd6-8831-3fcc702aa324

Public Version Date

July 09, 2020

Public Version Number

6

DI Record Publish Date

October 27, 2016

Package DI Number

10897392002975

Quantity per Package

6

Contains DI Package

00897392002244

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box