AEON

Basic Information

• Brand Name: AEON
• Primary DI: 00850060791048
• Version / Model: AEPH060
• Company Name: LEXINGTON MEDICAL, INC.
• Labeler DUNS: 079881514
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2024-05-24
• Public Version: 1
• Public Version Date: 2024-06-03
• Public Version Status: New
• Public Device Record Key: 04993b8d-92ce-44d2-a7d1-343bc2559227

Device Description

Endoscopic Powered Stapler - Short

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: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
GAG	Stapler, Surgical	General Hospital	878.4740	2
GDW	Staple, Implantable	General, Plastic Surgery	878.4750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62383	Motorized cutting stapler handpiece	A hand-held, electrically-powered proximal component of a motorized cutting stapler designed to be used during endoscopic transection and resection of tissues and the creation of anastomoses, and/or during open surgery. It is typically a pistol-like device with battery pack, motor, and controls, and is intended to accept a separate connector endpiece/loading unit (neither are included) to cut the tissue and simultaneously apply surgical staples along the cut line. 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	00851574008356	GS1
Primary	00850060791048	GS1

Premarket Submissions

Submission Number	Supplement Number
K234039	000