Catalog Number

3472

Brand Name

PremierPro TSAHigh Viscosity Topical Skin Adhesive w/ Mesh 22cm

Version/Model Number

3472

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

K152476,K152476

Product Code

MPN

Product Code Name

Tissue Adhesive For The Topical Approximation Of Skin

Public Device Record Key

c62d91e7-8974-45d2-a3ef-f56bda94dcdd

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 19, 2017

Package DI Number

10818566019858

Quantity per Package

10

Contains DI Package

00818566019851

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case