Catalog Number

41767-19

Brand Name

Microscope Universal Tracking Array

Version/Model Number

41767-19

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 20, 2019

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

K092467

Product Code

HAW

Product Code Name

Neurological Stereotaxic Instrument

Public Device Record Key

52ad01b7-c101-4e90-972f-4d5e71478f01

Public Version Date

December 23, 2019

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-