NA

Basic Information

• Brand Name: NA
• Primary DI: 04055207043271
• Version / Model: 8834025
• Catalog Number: 8834.025
• Company Name: Richard Wolf GmbH
• Labeler DUNS: 315304071
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-26
• Public Version: 5
• Public Version Date: 2023-11-17
• Public Version Status: Update
• Public Device Record Key: 362371ab-f472-4935-842c-fec7d96752d4
• Distribution End Date: 2016-09-26

Device Description

RECTOSCOPE TUBE Ø 22MM WL 260MM WL 260mm, TL 307mm, insulated distal end, 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
GCM	ENDOSCOPE, RIGID	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36635	Rigid optical rectoscope, reusable	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. It is inserted into the body through the anus during rectoscopy. Anatomical images are transmitted to the user typically through relayed lens optics. This device is longer than a proctoscope to provide a deeper view and it is typically equipped with illumination in the distal end. It is typically used to examine the structures of the rectum for irregularities. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04055207043271	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	22	Millimeter
Length	260	Millimeter