STD-ADAPTABLE CLASS III MASK 155-122

GUDID D7751551220

STD-ADAPTABLE CLASS III MASK

GREAT LAKES ORTHODONTICS, LTD.

Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear
Primary Device IDD7751551220
NIH Device Record Key57559185-bc45-4d5d-bac0-8c1db061e507
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTD-ADAPTABLE CLASS III MASK
Version Model Number155-122
Catalog Number155-122
Company DUNS041854332
Company NameGREAT LAKES ORTHODONTICS, LTD.
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD7751551220 [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 Date2016-05-18

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D7753006260 - GL INTRAORAL MOUTH PROPS 2018-10-05 GL INTRAORAL MOUTH PROPS
D7753006270 - GL INTRAORAL MOUTH PROPS 2018-10-05 GL INTRAORAL MOUTH PROPS
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