Catalog Number

-

Brand Name

belter

Version/Model Number

SF-371

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

Yes

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

K122976,K122976,K122976

Product Code

MNW

Product Code Name

Analyzer, Body Composition

Public Device Record Key

74d887de-f6e4-40b2-a03e-871f4a379eb1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 09, 2017

Package DI Number

26947468500384

Quantity per Package

5

Contains DI Package

16947468500387

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

5pcs/box