Electrode Depth Stop Adapter - Electrode Depth Stop Adapters for - FHC, INC.

Duns Number:108179458

Device Description: Electrode Depth Stop Adapters for microTargeting(TM) Drive System, 4x

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More Product Details

Catalog Number

66-AC-DS

Brand Name

Electrode Depth Stop Adapter

Version/Model Number

66-AC-DS-00518

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

-

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,K011992

Product Code Details

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Device Record Status

Public Device Record Key

9f22e9d9-0748-4a8e-9bf2-21accd6d4ce7

Public Version Date

July 06, 2018

Public Version Number

3

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