Catalog Number

3470

Brand Name

exofin HVTSA Premier Pro, 1g

Version/Model Number

3470

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,K152476

Product Code

MPN

Product Code Name

Tissue Adhesive For The Topical Approximation Of Skin

Public Device Record Key

f7f62b26-8253-4db4-9c31-847fd7dccf6a

Public Version Date

February 15, 2022

Public Version Number

2

DI Record Publish Date

November 08, 2021

Package DI Number

10854137001679

Quantity per Package

10

Contains DI Package

00854137001672

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack