Catalog Number

-

Brand Name

BioStamp® nPoint

Version/Model Number

MC00022

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"

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

K173510

Product Code

DRG

Product Code Name

Transmitters And Receivers, Physiological Signal, Radiofrequency

Public Device Record Key

b1ea5862-63b0-4695-928a-7c5a7100dfb3

Public Version Date

March 09, 2021

Public Version Number

1

DI Record Publish Date

March 01, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-