NA

Basic Information

• Brand Name: NA
• Primary DI: 04055207019382
• Version / Model: 8670961
• Catalog Number: 8670.961
• Company Name: Richard Wolf GmbH
• Labeler DUNS: 315304071
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 6
• Public Version Date: 2023-01-25
• Public Version Status: Update
• Public Device Record Key: 3e99d8ca-98b4-446e-a883-772ff94c4b9a

Device Description

SCALPEL 16.5FR CERAMIC SEMICIRCULAR for optical urethrotome, telescope Ø 3.3mm, massive, 12 O'clock cutting position, for slitting of urethral (transurethral) and ureteral (percutaneous) stenosis, reusable

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EZO	Urethrotome	Gastroenterology, Urology	876.4770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35141	Scalpel, reusable	A hand-held manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The device is typically made of high-grade stainless steel alloy. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04055207019382	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	5.5	Millimeter