HiRes™ Ultra Reusable Surgical Tools Kit

Basic Information

• Brand Name: HiRes™ Ultra Reusable Surgical Tools Kit
• Primary DI: 07630016835223
• Version / Model: CI-4509
• Company Name: Advanced Bionics AG
• Labeler DUNS: 485262658
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-20
• Public Version: 5
• Public Version Date: 2024-02-22
• Public Version Status: Update
• Public Device Record Key: d0efc59d-3b06-4585-a7ed-de99fa4007bf
• Distribution End Date: 2024-05-26

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MCM	Implant, Cochlear	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
44067	ENT surgical procedure kit, non-medicated, reusable	A collection of various ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07630016835223	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P960058	119