Catalog Number

-

Brand Name

innotech

Version/Model Number

EF-655B4

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"

-

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

PUH

Product Code Name

Analyzer, Body Composition, Exempt

Public Device Record Key

761c34be-2a68-42f2-83b1-3ae56d935a56

Public Version Date

January 06, 2020

Public Version Number

1

DI Record Publish Date

December 27, 2019

Package DI Number

26947468554738

Quantity per Package

5

Contains DI Package

16947468554731

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

5pcs/box