Multi-Adjustable Face Mask

GUDID D828FM220017296

FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC

Orthodontic extraoral headgear
Primary Device IDD828FM220017296
NIH Device Record Keye274b669-0c76-48ac-b24f-4eebd01cac66
Commercial Distribution StatusIn Commercial Distribution
Brand NameMulti-Adjustable Face Mask
Version Model NumberFM220017296
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
HIBCCD828FM220017296 [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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