Catalog Number

-

Brand Name

Midas Rex MR8

Version/Model Number

PM800N

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K183644

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Public Device Record Key

9e41d250-4bdf-4356-aa45-f7e0ad72bdbe

Public Version Date

August 16, 2019

Public Version Number

1

DI Record Publish Date

August 08, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-