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
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

04055207068243 - VERTEBRIS2026-02-18 KNOT PUSHER Ø 2.5MM WL 330MM reusable
04055207069691 - NA2026-02-18 CAGE SLEEVE ID 15MM OD 16 mm, TL 145 mm, reusable
04055207069707 - NA2026-02-18 CAGE SLEEVE SQUARE ID 15MM OD 16 mm, TL 145 mm, reusable
04055207069714 - NA2026-02-18 CAGE SLEEVE SQUARE ID 13.6MM OD 14,6 mm, TL 145 mm, reusable
04055207069721 - NA2026-02-18 CAGE SLEEVE ID 13.6MM OD 14,6 mm, TL 145 mm, reusable
04055207069738 - NA2026-02-18 DILATOR SQUARE ID 9.5MM OD 14.9MM TL 210 mm, reusable
04055207069745 - NA2026-02-18 DILATOR SQUARE ID 9.5MM OD 13.5MM TL 210 mm, reusable
04055207069790 - NA2026-01-22 KERRISON SHEATH W 5MM CURVED 40° for use with Kerrison handle, WL 130 mm, reusable

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.