Catalog Number

CP-SFW-11-20

Brand Name

ClearPoint

Version/Model Number

CP-SFW-11-20

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 23, 2021

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

-

Product Code

ORR

Product Code Name

Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri

Public Device Record Key

50b3fea7-dea6-4d32-a58c-f04202a0f451

Public Version Date

February 01, 2021

Public Version Number

1

DI Record Publish Date

January 22, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-