Catalog Number

-

Brand Name

BodyTrace

Version/Model Number

BT006

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

e4df48df-1409-40d2-9c73-f7479af2a7b7

Public Version Date

November 11, 2021

Public Version Number

1

DI Record Publish Date

November 03, 2021

Package DI Number

B726BT0061

Quantity per Package

1

Contains DI Package

B726BT0060

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Individual box