Catalog Number

-

Brand Name

ClearPoint Array

Version/Model Number

CPA-SFW-11-1

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"

-

For Single-Use

-

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

K202575

Product Code

HAW

Product Code Name

Neurological Stereotaxic Instrument

Public Device Record Key

e50c1a1d-2c81-4d91-bf01-7857de15f7b3

Public Version Date

June 21, 2022

Public Version Number

2

DI Record Publish Date

April 07, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-