Catalog Number

EE5

Brand Name

Integra® Miltex®

Version/Model Number

EE5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 01, 2022

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"

-

For Single-Use

-

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

EKB

Product Code Name

EXPLORER, OPERATIVE

Public Device Record Key

bf180726-a5bf-4d06-b2ea-a9bd57974810

Public Version Date

July 13, 2022

Public Version Number

3

DI Record Publish Date

April 19, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-