HELMUT ZEPF

Basic Information

• Brand Name: HELMUT ZEPF
• Primary DI: EZPF19649050
• Version / Model: 19.649.05
• Catalog Number: 19.649.05
• Company Name: Helmut Zepf Medizintechnik GmbH
• Labeler DUNS: 320001431
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-30
• Public Version: 2
• Public Version Date: 2024-02-06
• Public Version Status: Update
• Public Device Record Key: 629976ed-72c2-4208-8e76-0499d42fe63b

Device Description

CLIPS TO FIX THE RINSING HOSE ON THE ASPIRATOR, SET CONSISTING OF: 2X 19.649.06 AND 1X 19.649.07

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: No
• 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
KCB	TUBE, TONSIL SUCTION	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38759	Dental suction system cannula, reusable	A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is made of metal or plastic materials that can be sterilized. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EZPF19649050	HIBCC

Customer Contacts

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