microTargeting™ Platform Tool Guide - microTargeting Platform Tool Guide, 1x, nonsterile - FHC, INC.

Duns Number:108179458

Device Description: microTargeting Platform Tool Guide, 1x, nonsterile

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More Product Details

Catalog Number

66-WP-TG18MM

Brand Name

microTargeting™ Platform Tool Guide

Version/Model Number

66-WP-TG18MM-00362

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K092192

Product Code Details

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Device Record Status

Public Device Record Key

7f88c86e-7873-4a08-9648-3e38c1403058

Public Version Date

August 04, 2020

Public Version Number

5

DI Record Publish Date

September 17, 2016

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