Osia® 2 Sound Processor Magnet Tool

Basic Information

• Brand Name: Osia® 2 Sound Processor Magnet Tool
• Primary DI: 09321502046626
• Version / Model: Osia 2 System
• Catalog Number: P1631253
• Company Name: COCHLEAR LIMITED
• Labeler DUNS: 750551194
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-05
• Public Version: 1
• Public Version Date: 2020-09-14
• Public Version Status: New
• Public Device Record Key: 18f92f05-3b16-467d-9923-1aee5d066c2d

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: 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
PFO	Active implantable bone conduction hearing system	Ear, Nose, Throat	874.3340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64988	Hearing implant system external magnet inserter/remover	A noninvasive hand-held manual instrument designed to aid insertion, reinsertion and/or removal of the external magnet component of a hearing implant system (typically the sound processor magnet). It is typically made of polymer and magnetic materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09321502046626	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K191921	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature