Catalog Number

-

Brand Name

IDEA Health

Version/Model Number

ID-WS809

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

FRI

Product Code Name

Scale, Stand-On, Patient

Public Device Record Key

586839a1-dc09-4b0d-9f71-5ff3ef02f3fc

Public Version Date

April 16, 2021

Public Version Number

1

DI Record Publish Date

April 08, 2021

Package DI Number

G057IDWS8091

Quantity per Package

1

Contains DI Package

G057IDWS8090

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

individual box