Catalog Number

3470

Brand Name

PremierPro TSA High Viscosity Topical Skin Adhesive, 1.0ml

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"

Yes

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

-

Product Code

MPN

Product Code Name

Tissue Adhesive For The Topical Approximation Of Skin

Public Device Record Key

37e411c8-b374-4956-9707-17f3b4c5f6cd

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 19, 2017

Package DI Number

10818566019834

Quantity per Package

10

Contains DI Package

00818566019837

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

10/box