Catalog Number

-

Brand Name

BioStamp®

Version/Model Number

BRCA02

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 01, 2021

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DRG

Product Code Name

Transmitters And Receivers, Physiological Signal, Radiofrequency

Public Device Record Key

6b6414f4-e127-4284-a6b4-333a52604ecb

Public Version Date

April 02, 2021

Public Version Number

4

DI Record Publish Date

August 31, 2018

Package DI Number

B493MC0009

Quantity per Package

42

Contains DI Package

B493BRCA02

Package Discontinue Date

April 01, 2021

Package Status

Not in Commercial Distribution

Package Type

Box