Catalog Number

C408667

Brand Name

OPTIS™

Version/Model Number

Mobile System

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

b63a682a-ecc3-4dbb-b792-290732d0bd61

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 21, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-