NA

Basic Information

• Brand Name: NA
• Primary DI: 04055207011270
• Version / Model: 883890
• Catalog Number: 8838.90
• 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: 4
• Public Version Date: 2022-06-16
• Public Version Status: Update
• Public Device Record Key: e2e1350f-39b6-433d-8fb2-ff35ffc617d6
• Distribution End Date: 2016-09-26

Device Description

PROCTO-RECTOSCOPE HANDLE with cold light illumination, 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
63885	Rectoscope/proctoscope handle	A manual device intended to be used as a handle to hold a rectoscope or proctoscope during an examination procedure. It also typically provides attachment sites for inflation and illumination devices, and an end observation window. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04055207011270	GS1

Customer Contacts

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