Catalog Number

3475

Brand Name

exofin Precision Pen Premier Pro, 1g

Version/Model Number

3475

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

K212246,K212246

Product Code

MPN

Product Code Name

Tissue Adhesive For The Topical Approximation Of Skin

Public Device Record Key

7eae044d-c9cd-4c65-8ae9-ad246e19b76d

Public Version Date

February 15, 2022

Public Version Number

2

DI Record Publish Date

December 08, 2021

Package DI Number

10854137001655

Quantity per Package

12

Contains DI Package

00854137001658

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack