WayPoint™ Surgical Kit 66-WP-MR

GUDID 00873263001721

WayPoint Surgical Kit Contains: Anchor Hex Wrench - 66-WP-HW Burr Hole Entry Marker Tool & Bushing 66-MP-EM STar SteriSuite Case 6mm Standoff Wrench - 66-WP-SW WayPoint Driver Handle - 66-WP-DH Combination Driver Bit - 66-WP-CD microTargeting Sterilization Tray - 67-00-1

FHC, INC.

Neurological stereotactic surgery system
Primary Device ID00873263001721
NIH Device Record Keydde21ac7-b7d8-4367-b7ad-678f7e6dbbd0
Commercial Distribution StatusIn Commercial Distribution
Brand NameWayPoint™ Surgical Kit
Version Model Number66-WP-MR-00317
Catalog Number66-WP-MR
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
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

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
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
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
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
GS100873263001721 [Direct Marking]
GS100873263003176 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00873263001721]

Moist Heat or Steam Sterilization


[00873263001721]

Moist Heat or Steam Sterilization


[00873263001721]

Moist Heat or Steam Sterilization


[00873263001721]

Moist Heat or Steam Sterilization


[00873263001721]

Moist Heat or Steam Sterilization


[00873263001721]

Moist Heat or Steam Sterilization


[00873263001721]

Moist Heat or Steam Sterilization


[00873263001721]

Moist Heat or Steam Sterilization


[00873263001721]

Moist Heat or Steam Sterilization


[00873263001721]

Moist Heat or Steam Sterilization


[00873263001721]

Moist Heat or Steam Sterilization


[00873263001721]

Moist Heat or Steam Sterilization


[00873263001721]

Moist Heat or Steam Sterilization


[00873263001721]

Moist Heat or Steam Sterilization


[00873263001721]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-17

On-Brand Devices [WayPoint™ Surgical Kit]

00873263001721WayPoint Surgical Kit Contains: Anchor Hex Wrench - 66-WP-HW Burr Hole Entry Marker Tool & Bush
00873263003046WayPoint Disposable Surgical Kit, sterile

Trademark Results [WayPoint]

Mark Image

Registration | Serial
Company
Trademark
Application Date
WAYPOINT
WAYPOINT
98767300 not registered Live/Pending
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2024-09-24
WAYPOINT
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98761917 not registered Live/Pending
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2024-09-20
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98740509 not registered Live/Pending
New Meridian Corporation
2024-09-09
WAYPOINT
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KTW Group, Inc
2024-08-07
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98423275 not registered Live/Pending
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2024-02-27
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98423270 not registered Live/Pending
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2024-02-27
WAYPOINT
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97838679 not registered Live/Pending
Ridgeline International, Inc.
2023-03-14
WAYPOINT
WAYPOINT
97838636 not registered Live/Pending
Ridgeline International, Inc.
2023-03-14
WAYPOINT
WAYPOINT
97308720 not registered Live/Pending
Liquidstar, LLC
2022-03-11
WAYPOINT
WAYPOINT
97118087 not registered Live/Pending
Samtech, LLC
2021-11-10
WAYPOINT
WAYPOINT
97031350 not registered Live/Pending
Waypoint Investors, LLC
2021-09-16
WAYPOINT
WAYPOINT
97005243 not registered Live/Pending
Rivian IP Holdings, LLC
2021-08-31

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