Catalog Number

CPA-WK-01

Brand Name

ClearPoint Array Workstation

Version/Model Number

CPA-WK-01

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

eb47a19c-b05b-4244-9980-1b80343309c1

Public Version Date

June 22, 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

-