COE ALGINATE™ 120005

GUDID 10386040004695

COE ALGINATE™ Normal set, mint, 1 x 5lb powder and 1 x scoop

Gc America Inc.

Silicone dental impression material
Primary Device ID10386040004695
NIH Device Record Key48608f0f-6d01-4130-bc4c-46f6bebaa22a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOE ALGINATE™
Version Model Number120005
Catalog Number120005
Company DUNS005473608
Company NameGc America Inc.
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 Usefalse
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

Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com

Device Dimensions

Weight5 Pound
Weight5 Pound
Weight5 Pound
Weight5 Pound
Weight5 Pound
Weight5 Pound
Weight5 Pound
Weight5 Pound
Weight5 Pound

Operating and Storage Conditions

Storage Environment TemperatureBetween 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110386040004695 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELWMATERIAL, IMPRESSION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-15
Device Publish Date2022-07-07

On-Brand Devices [COE ALGINATE™]

20386040004746COE ALGINATE™ Fast set, wild cherry, 1 x 1lb powder and 1 x scoop
20386040004722COE ALGINATE™ Normal set, wild cherry, 1 x 1lb powder and 1 x scoop
20386040004715COE ALGINATE™ Fast set, mint, 1 x 1lb powder and 1 x scoop
10386040004701COE ALGINATE™ Normal set, mint, 5 x 5lb powder (25lb total)
10386040004695COE ALGINATE™ Normal set, mint, 1 x 5lb powder and 1 x scoop
20386040004685COE ALGINATE™ Normal set, mint, 1 x 1lb powder and 1 x scoop

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