RETRACTOR - LARGE WHITE *I 300-406

GUDID D7753004060

RETRACTOR - LARGE WHITE *I

GREAT LAKES ORTHODONTICS, LTD.

Dental cheek retractor, professional, reusable
Primary Device IDD7753004060
NIH Device Record Key63366e02-7978-4fde-b5cb-66d36b728eeb
Commercial Distribution StatusIn Commercial Distribution
Brand NameRETRACTOR - LARGE WHITE *I
Version Model Number300-406
Catalog Number300-406
Company DUNS041854332
Company NameGREAT LAKES ORTHODONTICS, LTD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Customer Support Contacts

Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD7753004060 [Primary]

FDA Product Code

DYNMouthpiece, Saliva Ejector

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D7753004060]

Moist Heat or Steam Sterilization


[D7753004060]

Moist Heat or Steam Sterilization


[D7753004060]

Moist Heat or Steam Sterilization


[D7753004060]

Moist Heat or Steam Sterilization


[D7753004060]

Moist Heat or Steam Sterilization


[D7753004060]

Moist Heat or Steam Sterilization


[D7753004060]

Moist Heat or Steam Sterilization


[D7753004060]

Moist Heat or Steam Sterilization


[D7753004060]

Moist Heat or Steam Sterilization


[D7753004060]

Moist Heat or Steam Sterilization


[D7753004060]

Moist Heat or Steam Sterilization


[D7753004060]

Moist Heat or Steam Sterilization


[D7753004060]

Moist Heat or Steam Sterilization


[D7753004060]

Moist Heat or Steam Sterilization


[D7753004060]

Moist Heat or Steam Sterilization


[D7753004060]

Moist Heat or Steam Sterilization


[D7753004060]

Moist Heat or Steam Sterilization


[D7753004060]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-10-05
Device Publish Date2016-05-18

Devices Manufactured by GREAT LAKES ORTHODONTICS, LTD.

D7753004000 - SM DRYFIELD KIT RED *I 2018-10-05 SM DRYFIELD KIT RED *I
D7753004010 - LG DRYFIELD KIT WHITE *I 2018-10-05 LG DRYFIELD KIT WHITE *I
D7753004060 - RETRACTOR - LARGE WHITE *I 2018-10-05RETRACTOR - LARGE WHITE *I
D7753004060 - RETRACTOR - LARGE WHITE *I 2018-10-05 RETRACTOR - LARGE WHITE *I
D7753004140 - RETRACTOR - SMALL RED *I 2018-10-05 RETRACTOR - SMALL RED *I
D7753006120 - LARGE LIP RETRACTOR *O 2018-10-05 LARGE LIP RETRACTOR *O
D7753006140 - SMALL LIP RETRACTOR *O 2018-10-05 SMALL LIP RETRACTOR *O
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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