Rental Bone-Anchored Drill Kit

Basic Information

• Brand Name: Rental Bone-Anchored Drill Kit
• Primary DI: 09321502070690
• Version / Model: FUZ180
• Catalog Number: FUZ180
• Company Name: Cochlear Americas Corporation
• Labeler DUNS: 130866817
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-26
• Public Version: 1
• Public Version Date: 2023-07-04
• Public Version Status: New
• Public Device Record Key: 3d301e2b-e85b-4f33-9470-6dd3cff9daa1

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Lot/Batch Number: No
• 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
LXB	Hearing aid, bone conduction	Ear, Nose, Throat	874.3302	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65087	Bone-conduction hearing implant system implantation tool	A hand-held manual surgical instrument intended to assist with the implantation of the implantable component(s) of a bone-conduction hearing implant system (typically the magnet and/or vibration transmitter) into the temporal bone. It is typically in the form of a drill or pin; it may also have a component intended to sweep/scan (non-powered) the cranial bone surface to determine whether there is sufficient depth to place the implantable magnet. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09321502070690	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K955713	000