TrueDorsal Devices

GUDID 00860001703016

Mandible-repositioning sleep-disordered breathing orthosis

Primary Device ID	00860001703016
NIH Device Record Key	80e44bc0-9bca-4d89-bf0e-797593861130
Commercial Distribution Status	In Commercial Distribution
Brand Name	TrueDorsal Devices
Version Model Number	TrueDorsal
Company DUNS	030362516
Company Name	TRUE FUNCTION LABORATORY
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	false
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
GS1	00860001703016 [Primary]

LRK	Device, Anti-Snoring

Steralize Prior To Use	false
Device Is Sterile	false

00860001703009 - TrueFunction Adjustable Herbst Appliance	2019-09-09 Oral device used to treat obstructive sleep apnea
00860001703016 - TrueDorsal Devices	2019-09-09Oral device used to treat obstructive sleep apnea
00860001703016 - TrueDorsal Devices	2019-09-09 Oral device used to treat obstructive sleep apnea