NA

Basic Information

• Brand Name: NA
• Primary DI: 04055207011584
• Version / Model: 895527
• Catalog Number: 8955.27
• Company Name: Richard Wolf GmbH
• Labeler DUNS: 315304071
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-28
• Public Version: 2
• Public Version Date: 2023-05-24
• Public Version Status: Update
• Public Device Record Key: 8176a9d5-3ac1-496d-9bd7-de680d1d5ae7
• Distribution End Date: 2022-10-31

Device Description

TELESCOPE DILATOR 9-27FR set with 7 pcs, gradation 3Fr, TL 230mm, 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: Yes
• 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
KOE	Dilator, urethral	Gastroenterology, Urology	876.5520	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37142	Endoscopic-access dilator, reusable	A device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04055207011584	GS1

Customer Contacts

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