Capella2 Starter Kit

Basic Information

• Brand Name: Capella2 Starter Kit
• Primary DI: 00817020029931
• Version / Model: 8-69-42800
• Company Name: INTELLIGENT HEARING SYSTEMS CORP.
• Labeler DUNS: 154870455
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-07
• Public Version: 1
• Public Version Date: 2018-12-10
• Public Version Status: New
• Public Device Record Key: ddfb5ec6-9bf0-47d2-9455-490cbe40cc4f

Device Characteristics

• Single Use: Yes
• 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: 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
EWO	Audiometer	Ear, Nose, Throat	874.1050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62133	Audiometric ear tip	A non-sterile luminal device intended to be connected to the distal end of an audiometric sound delivery tube and inserted into the ear canal, to allow test sounds to be delivered to the ear in isolation from background noise. It is designed to create a seal inside the ear canal whilst allowing the sound tube to pass through the lumen. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817020029931	GS1

Premarket Submissions

Submission Number	Supplement Number
K061443	000