Innobyte Clinical Package

Basic Information

• Brand Name: Innobyte Clinical Package
• Primary DI: D091INNOCA010
• Version / Model: 1.0
• Catalog Number: INNOCA01
• Company Name: Kube Innovation Inc
• Labeler DUNS: 201096437
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-11
• Public Version: 1
• Public Version Date: 2022-01-19
• Public Version Status: New
• Public Device Record Key: 98aac9a5-3ccb-4d45-ab46-c48e25d79947

Device Description

The Innobyte is a measurement medical device for dental clinicians in the quantitative evaluations of a patient’s bite strength. Includes; 1 Innobyte Handpiece, 1 Mouthpiece Sensor, 100 Protective Sleeves, Wall-Mount USB charger, associated cables, Operations Manuals and Guides, & One Year Parts and Labor Warranty.

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: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
LBB	Dynamometer, Ac-Powered	Orthopedic	888.1240	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63455	Dynamometer attachment	A non-powered component of a dynamometer designed to be attached to the force gauge of the dynamometer to allow the patient to apply force to the gauge in the desired manner during use (i.e., assessment of neuromuscular function). It may be available in a variety of forms (e.g., cable, grip bar, wall pad, adaptor); it is not intended for pain testing. This is a reusable device.	No	Active
63454	Dynamometer force gauge	An electrically-powered component of a digital (electric) dynamometer intended to measure and display and/or communicate forces during assessment of neuromuscular function. It is a small unit with a built-in force sensor and is intended to be used with an appropriate dynamometer attachment(s); it is not a complete dynamometer. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D091INNOCA010	HIBCC

Customer Contacts

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