SnoreByte Tray 3519-5

GUDID B140351950

Clear tray, intended for use as a temporary or trial device in the treatment of snoring or obstructive sleep apnea.

Braebon Medical Corporation

Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis
Primary Device IDB140351950
NIH Device Record Key1fc25c97-0037-4203-a13c-92027c62ca9f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSnoreByte Tray
Version Model Number3519-5
Catalog Number3519-5
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 Kitfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB140351950 [Unit of Use]
HIBCCB140351951 [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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