Tap III Anti-Snoring Device

GUDID D82852001070

FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC

Mandible-repositioning sleep-disordered breathing orthosis
Primary Device IDD82852001070
NIH Device Record Key9631bce2-f37e-4915-b9fb-f4814c50b52f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTap III Anti-Snoring Device
Version Model Number5200107
Company DUNS113352686
Company NameFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC
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 Usetrue
Lot Batchfalse
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
HIBCCD82852001070 [Primary]

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 Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

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