Catalog Number

-

Brand Name

BV Medical

Version/Model Number

70-608-000

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

f5d5bcd0-d063-4e12-84b3-4b7cc59cb3d8

Public Version Date

October 25, 2018

Public Version Number

1

DI Record Publish Date

September 24, 2018

Package DI Number

00845821031365

Quantity per Package

6

Contains DI Package

00845821024718

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-