TrueFunction Adjustable Herbst Appliance

GUDID 00860001703009

Oral device used to treat obstructive sleep apnea

TRUE FUNCTION LABORATORY

Mandible-repositioning sleep-disordered breathing orthosis
Primary Device ID00860001703009
NIH Device Record Keyb5807bf5-3846-457f-bed4-3773598a0dba
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrueFunction Adjustable Herbst Appliance
Version Model NumberTrueHerbst
Company DUNS030362516
Company NameTRUE FUNCTION LABORATORY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860001703009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LRKDevice, Anti-Snoring

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-09
Device Publish Date2019-09-01

Devices Manufactured by TRUE FUNCTION LABORATORY

00860001703009 - TrueFunction Adjustable Herbst Appliance2019-09-09Oral device used to treat obstructive sleep apnea
00860001703009 - TrueFunction Adjustable Herbst Appliance2019-09-09 Oral device used to treat obstructive sleep apnea
00860001703016 - TrueDorsal Devices2019-09-09 Oral device used to treat obstructive sleep apnea
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