Catalog Number

CP-NGS-11-CG45-XG

Brand Name

ClearPoint

Version/Model Number

CP-NGS-11-CG45-XG

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

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

-

Product Code

ORR

Product Code Name

Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri

Public Device Record Key

e851ee9b-9c0a-4e20-8ff2-2c57064deb29

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

-