Catalog Number

-

Brand Name

CRW®

Version/Model Number

IF3000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 01, 2022

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

K063230

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Public Device Record Key

89ae956c-c668-4e7e-ad65-e0144f719944

Public Version Date

May 06, 2022

Public Version Number

5

DI Record Publish Date

July 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-