HELMUT ZEPF

Basic Information

• Brand Name: HELMUT ZEPF
• Primary DI: EZPF64021210010
• Version / Model: 64021.21.001
• Catalog Number: 64021.21.001
• Company Name: Helmut Zepf Medizintechnik GmbH
• Labeler DUNS: 320001431
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-16
• Public Version: 2
• Public Version Date: 2023-12-07
• Public Version Status: Update
• Public Device Record Key: 597d2d7e-83dc-445f-9d40-f279ae3856ba

Device Description

BLADE HOLDER INSERT FOR STANDARD BLADES, FIG. 10 - 15 USABLE FOR INDIVIDUAL HANDLES

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
GDZ	HANDLE, SCALPEL	General, Plastic Surgery	878.4800	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	EZPF64021210010	HIBCC

Customer Contacts

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