Catalog Number

-

Brand Name

STEREOTACTIC

Version/Model Number

2103-181

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

Yes

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

K831329

Product Code

HAW

Product Code Name

Neurological Stereotaxic Instrument

Public Device Record Key

9a508bf3-6a51-49ec-a8ba-cf0ebb12ee8e

Public Version Date

July 19, 2021

Public Version Number

1

DI Record Publish Date

July 09, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-