824.05

GUDID 04055207008140

NEEDLE ELECTRODE MONO 5FR WL 420MM for cystoscopy, electrode shape: needle, PACK=1 PC, reusable

Richard Wolf GmbH

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Primary Device ID04055207008140
NIH Device Record Key1a01ee2b-cc12-4644-9dfa-f73a87f233c6
Commercial Distribution StatusIn Commercial Distribution
Version Model Number82405
Catalog Number824.05
Company DUNS315304071
Company NameRichard Wolf GmbH
Device Count1
DM Exempttrue
Pre-market Exemptfalse
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

Device Dimensions

Length420 Millimeter
Outer Diameter1.66666666666 Millimeter
Length420 Millimeter
Outer Diameter1.66666666666 Millimeter
Length420 Millimeter
Outer Diameter1.66666666666 Millimeter
Length420 Millimeter
Outer Diameter1.66666666666 Millimeter
Length420 Millimeter
Outer Diameter1.66666666666 Millimeter
Length420 Millimeter
Outer Diameter1.66666666666 Millimeter
Length420 Millimeter
Outer Diameter1.66666666666 Millimeter
Length420 Millimeter
Outer Diameter1.66666666666 Millimeter
Length420 Millimeter
Outer Diameter1.66666666666 Millimeter
Length420 Millimeter
Outer Diameter1.66666666666 Millimeter
Length420 Millimeter
Outer Diameter1.66666666666 Millimeter
Length420 Millimeter
Outer Diameter1.66666666666 Millimeter
Length420 Millimeter
Outer Diameter1.66666666666 Millimeter
Length420 Millimeter
Outer Diameter1.66666666666 Millimeter
Length420 Millimeter
Outer Diameter1.66666666666 Millimeter
Length420 Millimeter
Outer Diameter1.66666666666 Millimeter
Length420 Millimeter
Outer Diameter1.66666666666 Millimeter
Length420 Millimeter
Outer Diameter1.66666666666 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104055207008140 [Primary]

FDA Product Code

FGAKit, nephroscope

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04055207008140]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[04055207008140]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[04055207008140]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[04055207008140]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[04055207008140]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[04055207008140]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[04055207008140]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[04055207008140]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[04055207008140]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[04055207008140]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[04055207008140]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[04055207008140]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[04055207008140]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[04055207008140]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[04055207008140]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[04055207008140]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[04055207008140]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[04055207008140]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-09-20
Device Publish Date2016-09-23

Devices Manufactured by Richard Wolf GmbH

04055207042991 - NA2025-01-13 FLEX. GRASP. FORCEPS 4FR WL 600MM pike-mouth, double action, TL 750 mm, non-dismantling, reusable
04055207043011 - NA2025-01-13 FLEX. GRASP. FORCEPS 4FR WL 600MM mouse tooth, double action, TL 750 mm, non-dismantling, reusable
04055207066218 - E-LINE2025-01-10 SHEATH FOR CYSTOSCOPE 21FR
04055207066225 - E-LINE2025-01-10 SHEATH FOR CYSTOSCOPE 23FR
00814334022252 - NA2025-01-09 RESECTOR Ø 4.5MM WL 460MM CURVED
04055207028902 - HYSAFE2025-01-09 GRASP. FORCEPS INSERT 5FR pike-mouth long, double action, WL 550 mm, with irrigation connection, take-apart, reusable
00814334022238 - NA2025-01-08 RESECTOR Ø 4.5MM WL 460MM CURVED
00814334022214 - NA2025-01-06 RESECTOR Ø 5.5MM WL 460MM STRAIGHT
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.