ZQuiet S.A.

GUDID 00858522003289

Contains 3 of each of the following packaged assemblies: ZQuiet S.A. Dental Size A Single Unit - DI: 00858522003234 ZQuiet S.A. Dental Size B Single Unit - DI: 00858522003241 ZQuiet S.A. Dental Size C Single Unit - DI: 00858522003258 ZQuiet S.A. Dental Size D Single Unit - DI: 00858522003265

SLEEPING WELL, LLC

Mandible-repositioning sleep-disordered breathing orthosis
Primary Device ID00858522003289
NIH Device Record Key195dd513-0ac0-49ed-987b-86c4cdba2aad
Commercial Distribution StatusIn Commercial Distribution
Brand NameZQuiet S.A.
Version Model NumberZQSA-XD12M
Company DUNS020904101
Company NameSLEEPING WELL, LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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
GS100858522003289 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [ZQuiet S.A.]

00858522003289Contains 3 of each of the following packaged assemblies: ZQuiet S.A. Dental Size A Single Unit -
00858522003265ZQuiet S.A. Dental Size D Single Unit
00858522003258ZQuiet S.A. Dental Size C Single Unit
00858522003241ZQuiet S.A. Dental Size B Single Unit
00858522003234ZQuiet S.A. Dental Size A Single Unit
00858522003227Oral Appliance System for Snoring and Obstructive Sleep Apnea Pack contains: (1) Size A mouthpie

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