MARCO - TAKAGI SEIKO CO.,LTD.

Duns Number:690907167

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

MARCO

Version/Model Number

MARCO NON CONSOLE DELUXE2 STAND

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 11, 2017

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

HMF

Product Code Name

Stand, Instrument, Ac-Powered, Ophthalmic

Device Record Status

Public Device Record Key

19fc8e87-7a0a-411c-8799-f0c159edb281

Public Version Date

August 09, 2021

Public Version Number

4

DI Record Publish Date

September 09, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TAKAGI SEIKO CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 20
2 A medical device with a moderate to high risk that requires special controls. 20