Catalog Number

1591-1

Brand Name

3M™ Durapore™

Version/Model Number

1591-1

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KGX

Product Code Name

Tape and bandage, adhesive

Public Device Record Key

3b12ab2f-abc7-4301-8fe3-6284ec549578

Public Version Date

October 23, 2019

Public Version Number

2

DI Record Publish Date

September 24, 2018

Package DI Number

04054596475939

Quantity per Package

10

Contains DI Package

04054596475922

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CTNS