5597203

GUDID 04055207070079

MEDIA ARCHIVE FILESHARE This module requires core.portal. It allows the storage of intraoperative data to an enabled directory in the hospital’s IT infrastructure. The module is required once for each file sharing approval.

Richard Wolf GmbH

Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software
Primary Device ID04055207070079
NIH Device Record Keyb4a620c8-11d1-435e-8d00-9c20e13418eb
Commercial Distribution StatusIn Commercial Distribution
Version Model Number5597203
Catalog Number5597203
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 Datetrue
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 Identifiers

Device Issuing AgencyDevice ID
GS104055207070079 [Primary]

FDA Product Code

OUGMedical device data system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-03
Device Publish Date2024-05-24

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
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