HELMUT ZEPF

Basic Information

• Brand Name: HELMUT ZEPF
• Primary DI: EZPF12302000
• Version / Model: 12.302.00
• Catalog Number: 12.302.00
• Company Name: Helmut Zepf Medizintechnik GmbH
• Labeler DUNS: 320001431
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-25
• Public Version: 2
• Public Version Date: 2024-02-28
• Public Version Status: Update
• Public Device Record Key: b08345b6-8b9f-4753-9472-127dfa7915a2

Device Description

BENEX II TOOTH EXTRACTION SYSTEM COMPLETE INCL. RACK AND BASKET THE COMPLETE SET CONTAINS:

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
EMG	FORCEPS, TOOTH EXTRACTOR, SURGICAL	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45147	Dental/maxillofacial surgical procedure kit, non-medicated, reusable	A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EZPF12302000	HIBCC

Customer Contacts

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