BioStamp® nPoint - Adhesive with hydrogel - Medidata Solutions, Inc.

Duns Number:840371087

Device Description: Adhesive with hydrogel

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More Product Details

Catalog Number

-

Brand Name

BioStamp® nPoint

Version/Model Number

BRCA02

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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

K173510,K173510,K173510

Product Code Details

Product Code

DRG

Product Code Name

Transmitters And Receivers, Physiological Signal, Radiofrequency

Device Record Status

Public Device Record Key

beb3550a-806b-4e8f-b6c5-3f2acb92f237

Public Version Date

April 09, 2021

Public Version Number

1

DI Record Publish Date

April 01, 2021

Additional Identifiers

Package DI Number

G012MC0009

Quantity per Package

42

Contains DI Package

G012BRCA02

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"MEDIDATA SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 24