COE TRAY PLASTIC™ 240194

GUDID D6582401941

COE TRAY PLASTIC™ Fast Set Liquid 1 gallon (4 1-qt. cans)

Gc America Inc.

Dental impression spacer
Primary Device IDD6582401941
NIH Device Record Key1782c779-4151-4513-8fd5-9212213fc9e7
Commercial Distribution Discontinuation2020-02-03
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCOE TRAY PLASTIC™
Version Model Number240194
Catalog Number240194
Company DUNS005473608
Company NameGc America Inc.
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 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
Email[email protected]

Device Dimensions

Total Volume3784 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD6582401941 [Primary]

FDA Product Code

EBHMATERIAL, IMPRESSION TRAY, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-02-11
Device Publish Date2017-02-10

Devices Manufactured by Gc America Inc.

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