Catalog Number

009.0030

Brand Name

NMControl

Version/Model Number

v.1.6.

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

-

Prescription Use (Rx)

-

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

6181743d-5dc2-4f22-9d2e-b29152d1e575

Public Version Date

June 27, 2019

Public Version Number

1

DI Record Publish Date

June 19, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-