SYMFIT 7.0 Package

Basic Information

• Brand Name: SYMFIT 7.0 Package
• Primary DI: 09008738515293
• Version / Model: 51529
• Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
• Labeler DUNS: 300764032
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-09
• Public Version: 6
• Public Version Date: 2023-11-03
• Public Version Status: Update
• Public Device Record Key: 149a9c0c-6544-4d3d-a7d7-53645e063ac1

Device Description

Fitting Software

Device Characteristics

• Single Use: No
• 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: No
• 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
MPV	Implant, Hearing, Active, Middle Ear, Partially Implanted	Unknown		3
PFO	Implantable Bone Conduction Hearing Aid	Ear, Nose, Throat	874.3340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60211	Audiometric/hearing device software	A software program intended to assist with the evaluation of a patient’s hearing capability and/or evaluate and adjust the settings of a hearing assistive device. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and intended to be used on a non-medical computerized device (e.g., smartphone, tablet).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09008738515293	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
DEN170009	000