Catalog Number

-

Brand Name

GoWISE USA

Version/Model Number

GW22027

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

255ec8a2-d03d-4955-86b3-fe967d48e8b0

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 23, 2016

Package DI Number

10853821006044

Quantity per Package

1

Contains DI Package

00853821006047

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case