Catalog Number

-

Brand Name

Integra®

Version/Model Number

3405183

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

-

Product Code Name

-

Public Device Record Key

b565e8e1-c33a-45fd-90c3-b5a427a29469

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

November 11, 2016

Package DI Number

30381780356077

Quantity per Package

10

Contains DI Package

10381780356073

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE