BIOCRYL ICE 8oz MONOMER

GUDID D7750470040

GREAT LAKES ORTHODONTICS, LTD.

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Primary Device IDD7750470040
NIH Device Record Key442ea77b-fd94-4670-82b9-3354ac3219d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOCRYL ICE 8oz MONOMER
Version Model Number047-004
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
HIBCCD7750470040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBIResin, Denture, Relining, Repairing, Rebasing

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 Date2016-08-11

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 2018-10-05 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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