Visualase Anchor Bolt Tools 9736537

GUDID 00873263009086

Visualase Anchor Bolt Tools (1) Sterilization & Storage Tray (1) Anchor Bolt Driver (1) Anchor Bolt Driver Guide for Stealth Autoguide (1) Anchor Bolt Driver Guide for Leksell Coordinate Frame (1) Anchor Bolt Driver Guide for ROSA ONE Brain (1) Anchor Bolt Driver Guide for CRW Stereotactic System

FHC, INC.

Neurological stereotactic surgery system
Primary Device ID00873263009086
NIH Device Record Keyc27e817c-3354-47e2-899e-30c8748e3be7
Commercial Distribution StatusIn Commercial Distribution
Brand NameVisualase Anchor Bolt Tools
Version Model Number9736537-00908
Catalog Number9736537
Company DUNS108179458
Company NameFHC, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100873263009086 [Primary]

FDA Product Code

HAOINSTRUMENT, SURGICAL, NON-POWERED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00873263009086]

Moist Heat or Steam Sterilization


[00873263009086]

Moist Heat or Steam Sterilization


[00873263009086]

Moist Heat or Steam Sterilization


[00873263009086]

Moist Heat or Steam Sterilization


[00873263009086]

Moist Heat or Steam Sterilization


[00873263009086]

Moist Heat or Steam Sterilization


[00873263009086]

Moist Heat or Steam Sterilization


[00873263009086]

Moist Heat or Steam Sterilization


[00873263009086]

Moist Heat or Steam Sterilization


[00873263009086]

Moist Heat or Steam Sterilization


[00873263009086]

Moist Heat or Steam Sterilization


[00873263009086]

Moist Heat or Steam Sterilization


[00873263009086]

Moist Heat or Steam Sterilization


[00873263009086]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-18
Device Publish Date2025-03-10

Devices Manufactured by FHC, INC.

00873263008690 - Nexframe2025-05-08 Bilateral Nexframe System for Medtronic StealthStation Navigation Systems
00873263008706 - NEXDRIVE™ w/DIG2025-05-08 MI-1000 NEXDRIVE™ Micropositioning Drive with Display Option
00873263008713 - NEXDRIVE™2025-05-08 MI-2000 NEXDRIVE™ Micropositioning Drive
00873263008720 - Nexprobe®2025-05-08 NP-1000 Nexprobe Image-guided Probe for use with the Nexframe Stereotactic System and Medtronic StealthStation Navigation System
00873263008904 - microTargeting™ Single Procedure Kit2025-05-08 microTargeting Single Procedure Kit, with microElectrode, tubes, sterile drape sleeve and cable. Contains: IT(BP2): Insertion Tu
00873263008928 - microTargeting™ Insertion Tube Set2025-05-08 microTargeting Single Electrode Insertion Tube Set Contains: 66-IT-01 (One IT(BP2), One PT(BP2), One Spacer Cleaning Tool, One E
00873263008935 - microTargeting™ Insertion Tube Set2025-05-08 microTargeting Array Electrode Insertion Tube Set, nonsterile, for use with mT Drive. Contains 6 of IT(AR1), 6 of IT(AR2), and 1
00873263009031 - microTargeting™ Electrode Cable2025-05-08 microTargeting Electrode Cable

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