Mondial® Monobloc - Mondial® Monobloc MB70, Green, Opt3 Pkg - FERNO-WASHINGTON, INC.

Duns Number:004239034

Device Description: Mondial® Monobloc MB70, Green, Opt3 Pkg

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More Product Details

Catalog Number

-

Brand Name

Mondial® Monobloc

Version/Model Number

0054269

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 15, 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)

-

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

FPO

Product Code Name

Stretcher, Wheeled

Device Record Status

Public Device Record Key

ad87ed3f-f2df-4e95-8cca-c18dc812454e

Public Version Date

July 10, 2018

Public Version Number

3

DI Record Publish Date

August 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FERNO-WASHINGTON, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 140