Guideline™ 4000 C0217

GUDID 00873263008645

Guideline™ 4000 5.0 Software, Version 2.2.0

FHC, INC.

Neurophysiologic monitoring system
Primary Device ID00873263008645
NIH Device Record Key98bacabe-9f64-4ff5-a18b-e3b438b9f901
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuideline™ 4000
Version Model NumberC0217-00864
Catalog NumberC0217
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 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
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
GS100873263008645 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLELECTRODE, DEPTH

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-27
Device Publish Date2022-09-19

Devices Manufactured by FHC, INC.

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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

Trademark Results [Guideline]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GUIDELINE
GUIDELINE
98651491 not registered Live/Pending
Guideline, Inc.
2024-07-16
GUIDELINE
GUIDELINE
98402043 not registered Live/Pending
PC Dreamscape Holdco
2024-02-12
GUIDELINE
GUIDELINE
97833006 not registered Live/Pending
PC Dreamscape Holdco
2023-03-10
GUIDELINE
GUIDELINE
88571367 not registered Live/Pending
Guideline Tackle Company
2019-08-08
GUIDELINE
GUIDELINE
87763129 5578832 Live/Registered
Guideline, Inc.
2018-01-19
GUIDELINE
GUIDELINE
87728316 5869011 Live/Registered
Guideline AS
2017-12-20
GUIDELINE
GUIDELINE
86769390 not registered Dead/Abandoned
Guideline Technologies, Inc.
2015-09-25
GUIDELINE
GUIDELINE
86471306 not registered Dead/Abandoned
Wells Fargo & Company
2014-12-04
GUIDELINE
GUIDELINE
79252573 not registered Live/Pending
Guideline Sweden AB
2018-09-13
GUIDELINE
GUIDELINE
79246619 not registered Live/Pending
Guideline Sweden AB
2018-09-03
GUIDELINE
GUIDELINE
79039800 3927772 Live/Registered
P.E.R. Flucht- und Rettungsleitsysteme G
2007-01-17
GUIDELINE
GUIDELINE
78884380 3717016 Live/Registered
MAQUET CARDIOVASCULAR LLC
2006-05-16

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