CUSA® Excel

Basic Information

• Brand Name: CUSA® Excel
• Primary DI: 10381780025832
• Version / Model: C0023
• Catalog Number: C0023
• Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED
• Labeler DUNS: 989925396
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 36
• Record Status: Published
• Publish Date: 2016-12-29
• Public Version: 8
• Public Version Date: 2023-04-14
• Public Version Status: Update
• Public Device Record Key: c5a2e700-a33a-4cbc-9b5e-6afc5a228e56

Device Description

CUSA® Excel Maintenance kit

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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LBK	Device, neurosurgical fragmentation and aspiration	Unknown		U
LFL	Instrument, ultrasonic surgical	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
34878	Surgical instrument/endoscope cleaning utensil, reusable	A non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M433C00231	HIBCC
Primary	10381780025832	GS1
Unit of Use	00381780025835	GS1

Customer Contacts

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