COMBIDRIVE EN

Basic Information

• Brand Name: COMBIDRIVE EN
• Primary DI: 04055207001523
• Version / Model: 409001201
• Catalog Number: 40900.1201
• Company Name: Richard Wolf GmbH
• Labeler DUNS: 315304071
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-21
• Public Version: 5
• Public Version Date: 2022-11-03
• Public Version Status: Update
• Public Device Record Key: 95271d13-e705-49b1-8888-a61a6e9e500a

Device Description

SPRAY ATTACHMENT for CombiDrive EN Motor Control Unit, for Clean Spray for cleaning of handpieces

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HET	LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)	Obstetrics/Gynecology	884.1720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37412	Medical device cleaning jet handpiece	A hand-operated device designed to regulate and direct a narrow stream (a jet) of water and/or air for the initial cleaning of laboratory glassware, pipettes, syringes, certain endoscopes, cannulae, surgical instruments and other devices prior to disinfection/sterilization. It is usually in the form of a pistol with an activation trigger, and may be fitted with different nozzles or a variable nozzle. It is typically connected via tubing to a tap (faucet) and/or a pressurized air source. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04055207001523	GS1

Customer Contacts

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