Catalog Number

-

Brand Name

Medisante

Version/Model Number

BC800 3G

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

-

Product Code

FRI

Product Code Name

Scale, Stand-On, Patient

Public Device Record Key

38409ca4-8698-4a8c-9f16-3a1578b671c5

Public Version Date

September 01, 2020

Public Version Number

1

DI Record Publish Date

August 24, 2020

Package DI Number

14719878870013

Quantity per Package

5

Contains DI Package

04719878870016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box