Balance - Greater Goods

Duns Number:189583599

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More Product Details

Catalog Number

-

Brand Name

Balance

Version/Model Number

0399

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

MNW

Product Code Name

Analyzer, Body Composition

Device Record Status

Public Device Record Key

4fc8329b-c2fa-41ba-b7ee-baeb16da2019

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 29, 2017

Additional Identifiers

Package DI Number

10875011003992

Quantity per Package

4

Contains DI Package

00875011003995

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"GREATER GOODS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 12
2 A medical device with a moderate to high risk that requires special controls. 30