Innobyte Clinical Package INNOCA01

GUDID D091INNOCA010

Dynamometer attachment

Primary Device ID	D091INNOCA010
NIH Device Record Key	98aac9a5-3ccb-4d45-ab46-c48e25d79947
Commercial Distribution Status	In Commercial Distribution
Brand Name	Innobyte Clinical Package
Version Model Number	1.0
Catalog Number	INNOCA01
Company DUNS	201096437
Company Name	Kube Innovation Inc
Device Count	1
DM Exempt	true
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	D091INNOCA010 [Primary]

LBB	Dynamometer, Ac-Powered

Steralize Prior To Use	false
Device Is Sterile	false

D091INNOCP030 - Innobyte Bilateral Clinical Package	2023-07-04 The Innobyte is a medical device for dental clinicians in the quantitative evaluations of a patient’s bite strength. Includes;
D091INNOMP030 - Innobyte Bilateral Mouthpiece Replacement	2023-07-04 The Innobyte Bilateral Mouthpiece Sensor is a measurement medical device for dental clinicians in the quantitative evaluations o
D091INNOCA010 - Innobyte Clinical Package	2022-01-19The 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.
D091INNOCA010 - Innobyte Clinical Package	2022-01-19 The Innobyte is a measurement medical device for dental clinicians in the quantitative evaluations of a patient’s bite strengt
D091INNOMP010 - Innobyte Full-Arch Mouthpiece Sensor	2022-01-19 The Innobyte Full-Arch Mouthpiece Sensor is a measurement medical device for dental clinicians in the quantitative evaluations o