Catalog Number

-

Brand Name

MARCO

Version/Model Number

MARCO ENCORE AUTOMATIC CHAIR

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 24, 2018

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

HME

Product Code Name

Chair, Ophthalmic, Ac-Powered

Public Device Record Key

5c0a66ea-38bb-48de-9ff2-9c49b57d4196

Public Version Date

October 24, 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

-