Catalog Number

CP-SFW-11-201

Brand Name

ClearPoint

Version/Model Number

CP-SFW-11-201

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

K181195

Product Code

HAW

Product Code Name

Neurological Stereotaxic Instrument

Public Device Record Key

50c651ef-4873-4871-a4c9-bf47f1221e8f

Public Version Date

June 27, 2022

Public Version Number

2

DI Record Publish Date

January 22, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-