Catalog Number

NGS-GT-02

Brand Name

SmartFrame

Version/Model Number

NGS-GT-02

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

HAW

Product Code Name

Neurological Stereotaxic Instrument

Public Device Record Key

3434a1f4-6c0c-4ce5-8943-b67bc3060211

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

-