Catalog Number

-

Brand Name

MARCO

Version/Model Number

MARCO TRIAL LENS FRAME

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 07, 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

-

Product Code

HPA

Product Code Name

Frame, Trial, Ophthalmic

Public Device Record Key

80caa0a8-204a-40f9-9201-4953542ad22b

Public Version Date

June 01, 2018

Public Version Number

3

DI Record Publish Date

September 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-