microTargeting™ Microtable™ Platform – Single - microTargeting(TM) Microtable(TM) Platform – - FHC, INC.

Duns Number:108179458

Device Description: microTargeting(TM) Microtable(TM) Platform – Single

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

66-MT-D1

Brand Name

microTargeting™ Microtable™ Platform – Single

Version/Model Number

66-MT-D1-00643

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 30, 2022

Issuing Agency

In GS1

Product Characteristics

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"

-

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

K132611

Product Code Details

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Device Record Status

Public Device Record Key

e091963c-5f33-48fc-aa9c-dca7e48b7509

Public Version Date

October 04, 2022

Public Version Number

4

DI Record Publish Date

January 23, 2018

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