HiFocus SlimJ Electrode Depth Gauge

Basic Information

• Brand Name: HiFocus SlimJ Electrode Depth Gauge
• Primary DI: 00840094454637
• Version / Model: CI-1605
• Company Name: Advanced Bionics, LLC
• Labeler DUNS: 803906382
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-09
• Public Version: 2
• Public Version Date: 2023-01-10
• Public Version Status: Update
• Public Device Record Key: 73af29c0-41ec-4143-94cd-046f22351c0a

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
61603	Cochlear electrode array depth gauge, single-use	A hand-held manual surgical instrument intended to be used during insertion of an electrode array into the cochlea during implantation of a cochlear implant, to determine the number of active bands that can be implanted, to measure insertion depth, and sometimes to assess cochlear lumen patency. It consists of a thin probe with depth markings mounted on a handle, made of metal [e.g., platinum (Pt)] and synthetic polymers (e.g., silicone). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840094454637	GS1
Previous	07630016854842	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P960058	121

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal