SnoreByte Kit 3520-5

GUDID B140035201

Kit including the Silent Sleeep tray, intended as a temporary or trial device in the treatment of snoring or obstructive sleep apnea. Kit contains mixing tip, Silent Sleep Tray, toothbrush, OrthoFresh.

Braebon Medical Corporation

Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis
Primary Device IDB140035201
NIH Device Record Key36827709-bcb7-4dfa-b188-dfb8544c96dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameSnoreByte Kit
Version Model Number3520-5
Catalog Number3520-5
Company DUNS251731105
Company NameBraebon Medical Corporation
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB140035201 [Unit of Use]
HIBCCB140035202 [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 Date2023-06-19
Device Publish Date2023-06-09

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