microTargeting™ Single Electrode Carrier Set - Single Electrode Adapter for IT(ME1), 1x - FHC, INC.

Duns Number:108179458

Device Description: Single Electrode Adapter for IT(ME1), 1x

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More Product Details

Catalog Number

66-EL-EA-01

Brand Name

microTargeting™ Single Electrode Carrier Set

Version/Model Number

66-EL-EA-01-00859

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

-

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

K011992

Product Code Details

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Device Record Status

Public Device Record Key

1697aeab-1d6b-43be-9cd0-83075bf9ef34

Public Version Date

June 16, 2022

Public Version Number

1

DI Record Publish Date

June 08, 2022

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