microTargeting™ Insertion Tube - microTargeting Lead Insertion Tube with Stylet, - FHC, INC.

Duns Number:108179458

Device Description: microTargeting Lead Insertion Tube with Stylet, 5x, Sterile, Array for use with NexFrame a microTargeting Lead Insertion Tube with Stylet, 5x, Sterile, Array for use with NexFrame and mT Drive.

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


More Product Details

Catalog Number

FC7140LI

Brand Name

microTargeting™ Insertion Tube

Version/Model Number

FC7140LI-00764

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K011775,K011775

Product Code Details

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Device Record Status

Public Device Record Key

86e8604d-f523-4bd5-923e-c70c8f7f0ada

Public Version Date

January 06, 2020

Public Version Number

1

DI Record Publish Date

December 27, 2019

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