HELMUT ZEPF

Basic Information

• Brand Name: HELMUT ZEPF
• Primary DI: EZPF2601005OX0
• Version / Model: 26.010.05OX
• Catalog Number: 26.010.05OX
• Company Name: Helmut Zepf Medizintechnik GmbH
• Labeler DUNS: 320001431
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-05
• Public Version: 2
• Public Version Date: 2024-01-15
• Public Version Status: Update
• Public Device Record Key: 92ae2ac9-7076-4a57-90d7-662df6c8f2b7

Device Description

HANDLE, INSTRUMENT, DENTAL Z-SHAPE RELAX HANDLE, NANOPAL DOUBLE-ENDED M4X0,5 FOR CURETTES&SCALER

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
EJB	HANDLE, INSTRUMENT, DENTAL	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12235	Scalpel handle, reusable	A device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EZPF2601005OX0	HIBCC

Customer Contacts

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