Catalog Number

FS007

Brand Name

AESCULAP

Version/Model Number

FS007

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 25, 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

-

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Public Device Record Key

71856d55-9f89-4413-a6f7-94936e8ce761

Public Version Date

May 03, 2022

Public Version Number

4

DI Record Publish Date

February 26, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-