RIWO D-URS

Basic Information

• Brand Name: RIWO D-URS
• Primary DI: 04055207064177
• Version / Model: 473572076
• Catalog Number: 473572076
• Company Name: Richard Wolf GmbH
• Labeler DUNS: 315304071
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2021-05-17
• Public Version: 2
• Public Version Date: 2023-11-03
• Public Version Status: Update
• Public Device Record Key: 8292d003-822f-4b30-9dc2-5472364b52f2

Device Description

SENSOR-URETERORENOSCOPE 9FR WL 600MM flexible, working channel 1: 3,6FR, working channel 2: 1,65FR, PU= 3 pcs, sterile, for single use

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FGB	Ureteroscope and accessories, flexible/rigid	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63516	Rigid video ureterorenoscope	An endoscope with a rigid or semi-rigid inserted portion intended for the visual examination and treatment of the ureter and the renal pelvis; some types may have a flexible tip at the distal end of the inserted portion. It is inserted through the external urethral orifice during a urological procedure whereby anatomical images are transmitted by a video system via an image sensor chip at the distal end of the endoscope and displayed on a monitor. This device is typically used for the removal or crushing of stones, and evaluation of pyelitis and renal failure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	04055207064184	GS1
Primary	04055207064177	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K201897	000

Device Sizes

Type	Value	Unit	Text
Length	600	Millimeter
Outer Diameter	3	Millimeter

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 70 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius