Catalog Number

2103-125

Brand Name

PMT CORPORATION - STEREOTACTIC

Version/Model Number

2103-125

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 08, 2021

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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"

Yes

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

K831329

Product Code

HAW

Product Code Name

Neurological Stereotaxic Instrument

Public Device Record Key

287993d1-a7f0-4ace-b1fd-407ef57c1d1c

Public Version Date

July 09, 2021

Public Version Number

4

DI Record Publish Date

January 28, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-