Catalog Number

C408652

Brand Name

OPTIS™

Version/Model Number

Integrated 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

05f99ac0-877c-44ac-8283-1baf36bbaf39

Public Version Date

February 11, 2019

Public Version Number

3

DI Record Publish Date

September 28, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-