Stimulator Box

Basic Information

• Brand Name: Stimulator Box
• Primary DI: 09008737370053
• Version / Model: 37005
• 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: 2024-10-24
• Public Version: 1
• Public Version Date: 2024-11-01
• Public Version Status: New
• Public Device Record Key: 9478458e-a344-4743-8fb6-6a43eb340d0e

Device Description

Hardware Interface System

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
MCM	Implant, Cochlear	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
63366	Nerve location/function operative test pulse generator	An electrically-powered unit intended to produce electrical signals for preoperative and/or intraoperative application of electrical stimulation, via a connected hand-held probe with distal electrodes (not included), to a neural tissue site to: 1) locate nerves during surgery to prevent unintentional injury; 2) diagnose or assess nerve function; and/or 3) help determine an optimal electrical stimulation site prior to implantation of an active implant [e.g., cochlear implant (CI), auditory brainstem implant (ABI)]. It does not display electromyography (EMG) readings. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09008737370053	GS1

Premarket Submissions

Submission Number	Supplement Number
P000025	127