Catalog Number

DS16

Brand Name

CRW®

Version/Model Number

DS16

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K944463

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Public Device Record Key

cc2fec1a-41e2-449f-9af1-bd976f70c9f6

Public Version Date

September 16, 2019

Public Version Number

3

DI Record Publish Date

January 23, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-