Pedo Reverse Pull Face Mask

GUDID D8282200180

FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC

Orthodontic extraoral headgear
Primary Device IDD8282200180
NIH Device Record Key8bc85d58-80eb-46bb-9461-6d8ae765da54
Commercial Distribution StatusIn Commercial Distribution
Brand NamePedo Reverse Pull Face Mask
Version Model Number2200180
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 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
HIBCCD8282200180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZBHeadgear, Extraoral, Orthodontic

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 Date2016-10-04

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