LARGE LIP RETRACTOR *O 300-612

GUDID D7753006120

LARGE LIP RETRACTOR *O

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 IDD7753006120
NIH Device Record Key7d52f309-79ad-4558-9238-f3809fa2060d
Commercial Distribution StatusIn Commercial Distribution
Brand NameLARGE LIP RETRACTOR *O
Version Model Number300-612
Catalog Number300-612
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
HIBCCD7753006120 [Primary]

FDA Product Code

EIFAccessories, Retractor, Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D7753006120]

Moist Heat or Steam Sterilization

[D7753006120]

Moist Heat or Steam Sterilization

[D7753006120]

Moist Heat or Steam Sterilization

[D7753006120]

Moist Heat or Steam Sterilization

[D7753006120]

Moist Heat or Steam Sterilization

[D7753006120]

Moist Heat or Steam Sterilization

[D7753006120]

Moist Heat or Steam Sterilization

[D7753006120]

Moist Heat or Steam Sterilization

[D7753006120]

Moist Heat or Steam Sterilization

[D7753006120]

Moist Heat or Steam Sterilization

[D7753006120]

Moist Heat or Steam Sterilization

[D7753006120]

Moist Heat or Steam Sterilization

[D7753006120]

Moist Heat or Steam Sterilization

[D7753006120]

Moist Heat or Steam Sterilization

[D7753006120]

Moist Heat or Steam Sterilization

[D7753006120]

Moist Heat or Steam Sterilization

[D7753006120]

Moist Heat or Steam Sterilization

[D7753006120]

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 2018-10-05 RETRACTOR - LARGE WHITE *I
D7753004140 - RETRACTOR - SMALL RED *I 2018-10-05 RETRACTOR - SMALL RED *I
D7753006120 - LARGE LIP RETRACTOR *O 2018-10-05LARGE LIP RETRACTOR *O
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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.