VFS1 Footpedal C0841

GUDID 00873263008164

VFS1 Foot pedal, 1 x

FHC, INC.

Electrosurgical system generator
Primary Device ID00873263008164
NIH Device Record Key786f7b7d-6638-4ff7-9198-e07737a250fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameVFS1 Footpedal
Version Model NumberC0841-00816
Catalog NumberC0841
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
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 Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100873263008164 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, cutting & coagulation & accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-05
Device Publish Date2020-07-28

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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.