Unibody™ Bone Fiducials (7mm) FM-4007

GUDID 10873263007737

Unibody™ Bone Fiducials (7mm) for use with the Nexframe® Stereotactic System

FHC, INC.

Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system
Primary Device ID10873263007737
NIH Device Record Key1619c483-488e-48e6-bc08-02b3329a24fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnibody™ Bone Fiducials (7mm)
Version Model NumberFM-4007-00773
Catalog NumberFM-4007
Company DUNS108179458
Company NameFHC, INC.
Device Count6
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
GS100873263007730 [Unit of Use]
GS100873263007730 [Unit of Use]
GS100873263007730 [Unit of Use]
GS100873263007730 [Unit of Use]
GS110873263007737 [Primary]
GS110873263007737 [Primary]
GS110873263007737 [Primary]
GS110873263007737 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument
HAWNeurological stereotaxic Instrument
HAWNeurological stereotaxic Instrument
HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10873263007737]

Ethylene Oxide


[10873263007737]

Ethylene Oxide


[10873263007737]

Ethylene Oxide


[10873263007737]

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.

00873263007716 - NEXDRIVE™ w/DIG2020-11-10 MI-1000 NEXDRIVE™ Micropositioning Drive with Display Option
00873263007723 - NEXDRIVE™2020-11-10 MI-2000 NEXDRIVE™ Micropositioning Drive
10873263008215 - microTargeting™ Insertion Tube with Stylet2020-11-10 microTargeting™ Insertion Tube with Stylet, sterile
10873263007737 - Unibody™ Bone Fiducials (7mm)2020-11-10Unibody™ Bone Fiducials (7mm) for use with the Nexframe® Stereotactic System
10873263007737 - Unibody™ Bone Fiducials (7mm)2020-11-10 Unibody™ Bone Fiducials (7mm) for use with the Nexframe® Stereotactic System
10873263007744 - Unibody™ Bone Fiducials (10mm)2020-11-10 Unibody™ Bone Fiducials (10mm) for use with the Nexframe® Stereotactic System
10873263007751 - Unibody™ Bone Fiducials (13mm)2020-11-10 Unibody™ Bone Fiducials (13mm) for use with the Nexframe® Stereotactic System
00873263008096 - microTargeting™ Multi-Oblique Tool Guide2020-10-14 Multi-Oblique Platform 3.2mm Tool Guide (60mm), 1X
00873263008171 - microTargeting™ Insertion Tube with Stylet2020-09-18 microTargeting Insertion Tube with Stylet, nonsterile, 1x

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