Vibrating Ossicular Prosthesis (VORP 502B, left)

Basic Information

• Brand Name: Vibrating Ossicular Prosthesis (VORP 502B, left)
• Primary DI: 09008738501111
• Version / Model: 11333-001
• 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: 2014-09-22
• Public Version: 5
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: 8bd6cb39-c2b0-4bf3-8f0f-f355e14886f0

Device Description

Middle Ear Implant

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 Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• 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
MPV	Implant, Hearing, Active, Middle Ear, Partially Implanted	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
30084	Partially-implantable middle ear implant system	A battery-powered assembly of devices intended to compensate for impaired hearing by transmitting vibrations, from transduced sound waves, to the middle ear. It primarily consists of an external microphone and a vibrator implanted in the middle ear that is coupled with an ossicle (middle ear bone) or the oval window. The microphone receives sound waves and converts them into electrical signals (radio waves) which are sent to the vibrator for the transmission of vibrations to the middle ear bones to activate the auditory pathway. A middle ear implant (MEI) is typically used to treat sensorineural hearing loss (SNHL) or hearing impairment due to middle and/or outer ear obstructive pathologies.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09008738501111	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P990052	008
P990052	011
P990052	012
P990052	013
P990052	014
P990052	015
P990052	016
P990052	020
P990052	021
P990052	024

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 149 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -40 – 65 Degrees Celsius