Slim HP Standard Magnet

Basic Information

• Brand Name: Slim HP Standard Magnet
• Primary DI: 00840094445109
• Version / Model: CI-7524-002
• Company Name: Advanced Bionics, LLC
• Labeler DUNS: 803906382
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-13
• Public Version: 1
• Public Version Date: 2023-01-23
• Public Version Status: New
• Public Device Record Key: 830e915d-38f8-431f-b6b6-ec04a76b2ecf

Device Description

2

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
62944	Hearing implant system external magnet	A small, magnetic device intended to hold in place the sound processor and/or coil (not included) of a hearing implant system (e.g., cochlear, auditory brainstem, bone-conduction, partially-implantable middle ear implant system), to the outside of the scalp, typically by coupling with an implanted magnet. It is typically a magnetized metal disc that is attached to the processor/coil, but may be supplied separately.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Previous	07630016881657	GS1
Primary	00840094445109	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P960058	149

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 55 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 95 Percent (%) Relative Humidity