SICAT OPTISLEEP 10401

GUDID D776OSLEEPV110

Mandible-repositioning sleep-disordered breathing orthosis

Primary Device ID	D776OSLEEPV110
NIH Device Record Key	0e424d27-c96e-4886-87c1-d039171797ab
Commercial Distribution Status	In Commercial Distribution
Brand Name	SICAT OPTISLEEP
Version Model Number	V1.1
Catalog Number	10401
Company DUNS	333707003
Company Name	SiCAT GmbH & Co. KG
Device Count	1
DM Exempt	false
Pre-market Exempt	false
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	D776OSLEEPV110 [Primary]

LRK	Device, Anti-Snoring

Steralize Prior To Use	false
Device Is Sterile	false

Mark Image Registration \| Serial	Company Trademark Application Date
SICAT OPTISLEEP 79156825 4857226 Live/Registered	SiCAT GmbH & Co. KG 2014-09-26