Catalog Number

-

Brand Name

stimguide

Version/Model Number

666601

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K183376

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Public Device Record Key

7261974e-903e-49b3-8847-df96e122eac2

Public Version Date

August 26, 2020

Public Version Number

2

DI Record Publish Date

June 14, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-