2260003

GUDID 04055207063392

HF SURGERY GENERATOR 400KHZ for Urology, Gynecology, Surgery, for the connection of monopolar and bipolar accessories, international version for USA, monopolar connection Bovie, 3-pin, 4mm plug, bipolar connection, Erbe, Valleylab, touch screen, color display, compatible with core nova, connection socket for neutral electrode cable international, U: 100-240VAC, 50/60Hz, Dim. (wxhxd) 300x159x416

Richard Wolf GmbH

Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator

• Primary Device ID: 04055207063392
• NIH Device Record Key: 5d4af909-01c1-4317-9480-787797e7e3d8
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 2260003
• Catalog Number: 2260003
• Company DUNS: 315304071
• Company Name: Richard Wolf GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04055207063392 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230194

FDA Product Code

• GEI: Electrosurgical, cutting & coagulation & accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-17
• Device Publish Date: 2023-07-07

Devices Manufactured by Richard Wolf GmbH

• 04055207069776 - NA: 2024-04-09 SEAL Ø 11MM silicone seal, blue, for instruments 3-6mm, Length 2mm, reusable
• 04055207069783 - NA: 2024-04-09 SEALING MEMBRANE Ø 17MM yellow, Ø 17mm, PACK=10 PCS, for instruments from 3 to 6mm
• 04055207056691 - NA: 2024-04-08 LASER WORKING ELEMENT PASSIVE 12/30° closed, with locking mechanism for laser fibers, compatible with telescopes Ø 4mm, bayon
• 04055207056707 - NA: 2024-04-08 LASER WORKING INSERT 12/30° compatible with telescopes Ø 4mm, with locking mechanism for laser fiber, bayonet-lock, reusable
• 04055207057247 - NA: 2024-04-08 GUIDE SHEATH LASER THERAPY 1000µM 22FR with lateral guide, distal end straight, reusable
• 04055207057254 - NA: 2024-04-08 GUIDE SHEATH LASER THERAPY 1000µM 24FR with lateral guide, distal end straight, reusable
• 04055207057261 - NA: 2024-04-08 GUIDE SHEATH LASER THERAPY 600µM 22FR with lateral guide, distal end straight, reusable
• 04055207057278 - NA: 2024-04-08 GUIDE SHEATH LASER THERAPY 600µM 24FR with lateral guide, distal end straight, reusable