Dream TAP

GUDID D82852001090

FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC

Mandible-repositioning sleep-disordered breathing orthosis
Primary Device IDD82852001090
NIH Device Record Keye190669b-42e3-4cb3-b6cc-371b4f48bc53
Commercial Distribution StatusIn Commercial Distribution
Brand NameDream TAP
Version Model Number5200109
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
HIBCCD82852001090 [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 Date2017-12-12

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