ELAN 4

Basic Information

• Brand Name: ELAN 4
• Primary DI: 04046955157334
• Version / Model: GP523SU
• Catalog Number: GP523SU
• Company Name: Aesculap AG
• Labeler DUNS: 315018218
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-01
• Public Version: 4
• Public Version Date: 2021-01-22
• Public Version Status: Update
• Public Device Record Key: a8de4811-8503-4243-9836-e06e2ab266ed

Device Description

DISP.SAW BLADE L SAGITTAL 35/15/0.7

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
HBE	DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)	Neurology	882.4310	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43376	Surgical saw blade, sagittal, single-use	A flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a sternum saw blade). This device is designed with the cutting teeth arranged in an arc or on a flat plane pointing directly forward at the distal end to cut in a rapid sagittal (side to side) motion; it may in addition cut in an oscillating motion. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04046955157334	GS1

Customer Contacts

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