Catalog Number

-

Brand Name

GoWISE USA

Version/Model Number

GW22042

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

225d9c47-c01f-4346-a27b-bee14c331e0d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 29, 2017

Package DI Number

20819687020300

Quantity per Package

1

Contains DI Package

10819687020303

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton