Catalog Number

FC8014

Brand Name

Lower Lead Depth Stop

Version/Model Number

FC8014-00819

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 28, 2021

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

K092562

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Public Device Record Key

f993371e-dc71-49f1-9bfc-38f0841c1aa0

Public Version Date

July 29, 2021

Public Version Number

3

DI Record Publish Date

December 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-