NEXDRIVE™ MI-2000

GUDID 00873263007723

MI-2000 NEXDRIVE™ Micropositioning Drive

FHC, INC.

Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system
Primary Device ID00873263007723
NIH Device Record Keyf990fe02-b932-442d-8de8-0a3f164e339c
Commercial Distribution StatusIn Commercial Distribution
Brand NameNEXDRIVE™
Version Model NumberMI-2000-00772
Catalog NumberMI-2000
Company DUNS108179458
Company NameFHC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100873263007723 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00873263007723]

Ethylene Oxide


[00873263007723]

Ethylene Oxide


[00873263007723]

Ethylene Oxide


[00873263007723]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-10
Device Publish Date2020-11-02

Devices Manufactured by FHC, INC.

00873263005453 - microTargeting™ Multi-Oblique Accessory2024-03-14 Multi-Oblique Sterilization and Storage Kit
00873263007044 - microTargeting™ Electrode Sterilization Tray2024-03-14 microTargeting Electrode Sterilization Tray
00873263002216 - STar™ Drive Frame Adapter Kit2024-03-12 STar(TM) Drive Platform Adaptor, Integrated Ring Version
00873263002353 - STar™ Drive Frame Adapter2024-03-12 STar(TM) Drive Frame Adapter for use with Brain Lab(R)/Micromar stereotactic frames
00873263002384 - STar™ Drive Positioner2024-03-12 Offset Positioner, Short Bushing for STar(TM) Drive
00873263002452 - STar™ Drive Positioner2024-03-12 Center Positioner, Short Bushing for STar Drive
00873263002759 - STar™ Drive Lead Measurement Fixture2024-03-12 DBS Lead Measurement Fixture for STar(TM) Drive for use with Platform
00873263003312 - WayPoint™ Hex Wrench2024-03-12 WayPoint Hex Wrench

Trademark Results [NEXDRIVE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NEXDRIVE
NEXDRIVE
98147972 not registered Live/Pending
SHENZHEN TECHWINSEMI Technology Co., LTD
2023-08-24
NEXDRIVE
NEXDRIVE
97038013 not registered Live/Pending
Genuine Parts Company
2021-09-21
NEXDRIVE
NEXDRIVE
79353971 not registered Live/Pending
Alliance Automotive Group Benelux B.V.
2022-05-27
NEXDRIVE
NEXDRIVE
79353955 not registered Live/Pending
Alliance Automotive Group Benelux B.V.
2022-05-27
NEXDRIVE
NEXDRIVE
78943173 3812254 Dead/Cancelled
1384489 Ontario Inc.
2006-08-02
NEXDRIVE
NEXDRIVE
78753134 3235288 Live/Registered
Medtronic, Inc.
2005-11-14

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