RETRACTOR - SMALL RED *I 300-414

GUDID D7753004140

RETRACTOR - SMALL RED *I

GREAT LAKES ORTHODONTICS, LTD.

Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable
Primary Device IDD7753004140
NIH Device Record Key72dd7302-57da-409d-819a-d81763e13f20
Commercial Distribution StatusIn Commercial Distribution
Brand NameRETRACTOR - SMALL RED *I
Version Model Number300-414
Catalog Number300-414
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
HIBCCD7753004140 [Primary]

FDA Product Code

DYNMouthpiece, Saliva Ejector

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D7753004140]

Moist Heat or Steam Sterilization

[D7753004140]

Moist Heat or Steam Sterilization

[D7753004140]

Moist Heat or Steam Sterilization

[D7753004140]

Moist Heat or Steam Sterilization

[D7753004140]

Moist Heat or Steam Sterilization

[D7753004140]

Moist Heat or Steam Sterilization

[D7753004140]

Moist Heat or Steam Sterilization

[D7753004140]

Moist Heat or Steam Sterilization

[D7753004140]

Moist Heat or Steam Sterilization

[D7753004140]

Moist Heat or Steam Sterilization

[D7753004140]

Moist Heat or Steam Sterilization

[D7753004140]

Moist Heat or Steam Sterilization

[D7753004140]

Moist Heat or Steam Sterilization

[D7753004140]

Moist Heat or Steam Sterilization

[D7753004140]

Moist Heat or Steam Sterilization

[D7753004140]

Moist Heat or Steam Sterilization

[D7753004140]

Moist Heat or Steam Sterilization

[D7753004140]

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.

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D7753004010 - LG DRYFIELD KIT WHITE *I 2018-10-05 LG DRYFIELD KIT WHITE *I
D7753004060 - RETRACTOR - LARGE WHITE *I 2018-10-05 RETRACTOR - LARGE WHITE *I
D7753004140 - RETRACTOR - SMALL RED *I 2018-10-05RETRACTOR - SMALL RED *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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