ELAN 4

Basic Information

• Brand Name: ELAN 4
• Primary DI: 04046964910104
• Version / Model: MD791
• Catalog Number: MD791
• Company Name: AESCULAP, INC.
• Labeler DUNS: 082594540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2020-10-27
• Public Version: 1
• Public Version Date: 2020-11-04
• Public Version Status: New
• Public Device Record Key: 59a05a20-88f8-4b05-a771-c30fc3d7e4e6

Device Description

FISSURE BURR CARBIDE 1.6 X 70MM

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEY	MOTOR, SURGICAL INSTRUMENT, AC-POWERED	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43555	Burring power tool attachment	A device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a burring function when an appropriate bur is inserted. It may include integral design features, e.g., have an angled head or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	04046964910098	GS1
Primary	04046964910104	GS1

Customer Contacts

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