Visualase Neuro Accessories 9736536

GUDID 00873263009062

Visualase Neuro Accessories (1) Anchor Bolt (1) Stiffening Stylet (1) Anchor Bolt Removal Tool

FHC, INC.

Neurological stereotactic surgery system
Primary Device ID00873263009062
NIH Device Record Key9cea72f4-52c5-4539-98a0-cbb736943c0f
Commercial Distribution StatusIn Commercial Distribution
Brand NameVisualase Neuro Accessories
Version Model Number9736536-00906
Catalog Number9736536
Company DUNS108179458
Company NameFHC, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
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
GS100873263009062 [Primary]

FDA Product Code

HAOINSTRUMENT, SURGICAL, NON-POWERED

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00873263009062]

Ethylene Oxide


[00873263009062]

Ethylene Oxide


[00873263009062]

Ethylene Oxide


[00873263009062]

Ethylene Oxide


[00873263009062]

Ethylene Oxide


[00873263009062]

Ethylene Oxide


[00873263009062]

Ethylene Oxide


[00873263009062]

Ethylene Oxide


[00873263009062]

Ethylene Oxide


[00873263009062]

Ethylene Oxide


[00873263009062]

Ethylene Oxide


[00873263009062]

Ethylene Oxide


[00873263009062]

Ethylene Oxide


[00873263009062]

Ethylene Oxide


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.

00873263009062 - Visualase Neuro Accessories2025-03-18Visualase Neuro Accessories (1) Anchor Bolt (1) Stiffening Stylet (1) Anchor Bolt Removal Tool
00873263009062 - Visualase Neuro Accessories2025-03-18 Visualase Neuro Accessories (1) Anchor Bolt (1) Stiffening Stylet (1) Anchor Bolt Removal Tool
00873263009079 - Visualase MR Stiffening Stylet2025-03-18 Visualase MR Stiffening Stylet (1) MR Stiffening Stylet
00873263009086 - Visualase Anchor Bolt Tools2025-03-18 Visualase Anchor Bolt Tools (1) Sterilization & Storage Tray (1) Anchor Bolt Driver (1) Anchor Bolt Driver Guide for Stealth Aut
00873263009093 - Visualase Sterilization & Storage Tray2025-03-18 Visualase Sterilization & Storage Tray (1) Sterilization & Storage Tray
00873263009109 - Visualase Anchor Bolt Driver2025-03-18 Visualase Anchor Bolt Driver (1) Anchor Bolt Driver
00873263009116 - Visualase Anchor Bolt Driver Guide2025-03-18 Visualase Anchor Bolt Driver Guide for CRW (1) Anchor Bolt Driver Guide for CRW Stereotactic System
00873263009123 - Visualase Anchor Bolt Driver Guide2025-03-18 Visualase Anchor Bolt Guide for Leksell (1) Anchor Bolt Driver Guide for Leksell Coordinate Frame
00873263009130 - Visualase Anchor Bolt Driver Guide2025-03-18 Visualase Anchor Bolt Driver Guide for ROSA ONE (1) Anchor Bolt Driver Guide for ROSA ONE Brain

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