microTargeting™ Platform - Six-Trajectory Bilateral Platform - FHC, INC.

Duns Number:108179458

Device Description: Six-Trajectory Bilateral Platform

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More Product Details

Catalog Number

MP-KIT-P-SG

Brand Name

microTargeting™ Platform

Version/Model Number

MP-KIT-P-SG-00843

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

K092192

Product Code Details

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Device Record Status

Public Device Record Key

c844bdce-2417-4c45-b403-508053a08893

Public Version Date

November 05, 2021

Public Version Number

1

DI Record Publish Date

October 28, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FHC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 476