823.08

GUDID 00814334021163

BUTTON ELECTRODE 8FR WL 400MM MONO reusable

Richard Wolf GmbH

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Primary Device ID00814334021163
NIH Device Record Key4cd3a336-61a4-4af5-a27d-20bf24a67460
Commercial Distribution StatusIn Commercial Distribution
Version Model Number82308
Catalog Number823.08
Company DUNS315304071
Company NameRichard Wolf GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com

Device Dimensions

Outer Diameter2.66666666666 Millimeter
Outer Diameter2.66666666666 Millimeter
Outer Diameter2.66666666666 Millimeter
Outer Diameter2.66666666666 Millimeter
Length400 Millimeter
Outer Diameter2.66666666666 Millimeter
Length400 Millimeter
Outer Diameter2.66666666666 Millimeter
Length400 Millimeter
Outer Diameter2.66666666666 Millimeter
Length400 Millimeter
Outer Diameter2.66666666666 Millimeter
Length400 Millimeter
Outer Diameter2.66666666666 Millimeter
Length400 Millimeter
Outer Diameter2.66666666666 Millimeter
Length400 Millimeter
Outer Diameter2.66666666666 Millimeter
Length400 Millimeter
Outer Diameter2.66666666666 Millimeter
Length400 Millimeter
Outer Diameter2.66666666666 Millimeter
Length400 Millimeter
Outer Diameter2.66666666666 Millimeter
Length400 Millimeter
Outer Diameter2.66666666666 Millimeter
Length400 Millimeter
Outer Diameter2.66666666666 Millimeter
Length400 Millimeter
Outer Diameter2.66666666666 Millimeter
Length400 Millimeter
Outer Diameter2.66666666666 Millimeter
Length400 Millimeter
Outer Diameter2.66666666666 Millimeter
Length400 Millimeter
Outer Diameter2.66666666666 Millimeter
Length400 Millimeter
Outer Diameter2.66666666666 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100814334021163 [Primary]

FDA Product Code

JOSElectrode, electrosurgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00814334021163]

Moist Heat or Steam Sterilization


[00814334021163]

Moist Heat or Steam Sterilization


[00814334021163]

Moist Heat or Steam Sterilization


[00814334021163]

Moist Heat or Steam Sterilization


[00814334021163]

Moist Heat or Steam Sterilization


[00814334021163]

Moist Heat or Steam Sterilization


[00814334021163]

Moist Heat or Steam Sterilization


[00814334021163]

Moist Heat or Steam Sterilization


[00814334021163]

Moist Heat or Steam Sterilization


[00814334021163]

Moist Heat or Steam Sterilization


[00814334021163]

Moist Heat or Steam Sterilization


[00814334021163]

Moist Heat or Steam Sterilization


[00814334021163]

Moist Heat or Steam Sterilization


[00814334021163]

Moist Heat or Steam Sterilization


[00814334021163]

Moist Heat or Steam Sterilization


[00814334021163]

Moist Heat or Steam Sterilization


[00814334021163]

Moist Heat or Steam Sterilization


[00814334021163]

Moist Heat or Steam Sterilization


[00814334021163]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-30

Devices Manufactured by Richard Wolf GmbH

04055207036709 - POWER STICK M5/32024-07-16 MOTOR HANDPIECE MAX. 16000RPM with fixed connection cable, for use with rotation tools, with three function buttons, control op
04055207054765 - POWERSPEED AS12024-07-16 REMOTE FOOTSWITCH 2 PEDALS+2 BUTTONS for PowerSpeed AS1 Motor Control Unit, with optional backup cable
04055207056660 - POWERSPEED AS12024-07-16 MOTOR CONTROL UNIT 2305 for Orthopedics, Spine surgery and Bronchoscopy, for connection of motor handle M4. M5/0. M5/3. S1. M1
04055207063811 - X12024-07-16 HIGH-SPEED-MOTOR MAX. 50000RPM for use with High-Speed-attachments, control by footswitch, reusable
04055207063828 - NA2024-07-16 CONNECTION CABLE WL 3M For connecting the X1 motor to the 2305 Motor Control Unit, reusable
04055207067178 - NA2024-07-12 UNIVERSAL PERFORATED BASKET 4 Holds: Instruments, for sterilization (steam and low-temperature), storage and transport, inner d
04055207067185 - NA2024-07-12 UNIVERSAL PERFORATED BASKET 3 Holds: Instrument and accessories, for sterilization (steam and low-temperature), storage and tra
04055207067192 - NA2024-07-12 UNIVERSAL PERFORATED BASKET 2 Holds: Instrument and accessories, for sterilization (steam and low-temperature), storage and tra

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.