Catalog Number

E4-FULL-WW

Brand Name

OPTIS™

Version/Model Number

Metallic Stent Optimization Software

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"

-

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

NQQ

Product Code Name

SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)

Public Device Record Key

0be9c4c6-3fef-422c-bced-97ac49ee48f2

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-