Cochlear™ Magnet Cassette

Basic Information

• Brand Name: Cochlear™ Magnet Cassette
• Primary DI: 09321502070683
• Version / Model: P1773917
• Catalog Number: P1773917
• Company Name: COCHLEAR LIMITED
• Labeler DUNS: 750551194
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-15
• Public Version: 2
• Public Version Date: 2025-02-18
• Public Version Status: Update
• Public Device Record Key: a656c8f9-8848-426d-a328-5939a8ee0c3a

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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
PFO	Active implantable bone conduction hearing system	Ear, Nose, Throat	874.3340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62601	Cochlear implant implantable magnet	A small, sterile, magnetic device intended to be implanted subcutaneously within the implantable component of a cochlear implant system (CIS) and to couple with a magnet in the CIS external component, to hold implantable and external components in place. It is typically a magnetized metal disc contained within a non-reactive metal (e.g., titanium) case.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09321502070683	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K231204	000