Catalog Number

-

Brand Name

MARCO

Version/Model Number

MARCO ULTRAM3

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 10, 2017

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

K162636

Product Code

HJO

Product Code Name

Biomicroscope, Slit-Lamp, Ac-Powered

Public Device Record Key

f1d67e06-ca3e-410b-9e85-6bd129bb7e90

Public Version Date

April 08, 2022

Public Version Number

5

DI Record Publish Date

April 28, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-