inomed Adapter 66-WP-IN

GUDID 00873263008386

inomed Adapter for microTargeting™ Platform

FHC, INC.

Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system
Primary Device ID00873263008386
NIH Device Record Keybcf20936-f5be-4c3a-b221-2ae28cff8669
Commercial Distribution StatusIn Commercial Distribution
Brand Nameinomed Adapter
Version Model Number66-WP-IN-00838
Catalog Number66-WP-IN
Company DUNS108179458
Company NameFHC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100873263008386 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00873263008386]

Moist Heat or Steam Sterilization


[00873263008386]

Moist Heat or Steam Sterilization


[00873263008386]

Moist Heat or Steam Sterilization


[00873263008386]

Moist Heat or Steam Sterilization


[00873263008386]

Moist Heat or Steam Sterilization


[00873263008386]

Moist Heat or Steam Sterilization


[00873263008386]

Moist Heat or Steam Sterilization


[00873263008386]

Moist Heat or Steam Sterilization


[00873263008386]

Moist Heat or Steam Sterilization


[00873263008386]

Moist Heat or Steam Sterilization


[00873263008386]

Moist Heat or Steam Sterilization


[00873263008386]

Moist Heat or Steam Sterilization


[00873263008386]

Moist Heat or Steam Sterilization


[00873263008386]

Moist Heat or Steam Sterilization


[00873263008386]

Moist Heat or Steam Sterilization


[00873263008386]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-30
Device Publish Date2021-06-22

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00873263002193 - STar™ Drive Frame Adapter2024-05-22 STar(TM) Drive Frame Adapter for use with Leibinger ZD stereotactic frame
00873263002223 - STar™ Drive Frame Adapter2024-05-22 STar(TM) Drive Frame Adapter for use with Leibinger RM stereotactic frame
00873263002261 - STar™ Drive Frame Adapter2024-05-22 STar(TM) Drive Frame Adapter for use with Radionics CRW stereotactic frame
00873263002643 - STar™ Drive Lead Adapter2024-05-22 DBS Lead Adapter for STar(TM) Drive
00873263002728 - STar™ Drive Lead Measurement Fixture2024-05-22 DBS Lead Measurement Fixture for STar(TM) Drive for use with stereotactic frame
00873263002995 - STar™ Drive SteriSuite Case2024-05-22 Sterilzation Wire Basket for STar(TM) Drive System

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