Catalog Number

-

Brand Name

Integra®

Version/Model Number

SS3078A

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

Yes

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

-

FDA Premarket Submission

-

Product Code

-

Product Code Name

-

Public Device Record Key

b8dde863-f0a1-4271-996b-336b48a6ce01

Public Version Date

December 12, 2019

Public Version Number

3

DI Record Publish Date

September 30, 2016

Package DI Number

30381780264983

Quantity per Package

10

Contains DI Package

10381780264989

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE