eCement Try-In Paste C-531A1

GUDID 00810111542326

eCement Try-In Paste A1 2g Syringe

BISCO INC.

Dental cement trial
Primary Device ID00810111542326
NIH Device Record Key9af53e37-a10a-4715-b88a-9fca52e9aedd
Commercial Distribution StatusIn Commercial Distribution
Brand NameeCement Try-In Paste
Version Model NumberC-531A1
Catalog NumberC-531A1
Company DUNS053529939
Company NameBISCO 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(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100810111542326 [Primary]
HIBCCD757C531A10 [Previous]

FDA Product Code

EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-11
Device Publish Date2022-11-03

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D757C531TRP1eCement Try-In Paste Translucent 2g Syringe Pkg
D757C531MBP1eCement Try-In Paste Milky Bright 2g Syringe Pkg
D757C531A1P1eCement Try-In Paste A1 2g Syringe Pkg
D757C531TR0eCement Try-In Paste Translucent 2g Syringe
D757C531MB0eCement Try-In Paste Milky Bright 2g Syringe
D757C531A10eCement Try-In Paste A1 2g Syringe
00810111542371eCement Try-In Paste Milky Bright 2g Syringe Pkg
00810111542357eCement Try-In Paste Translucent 2g Syringe Pkg
00810111542364eCement Try-In Paste Milky Bright 2g Syringe
00810111542333eCement Try-In Paste A1 2g Syringe Pkg
00810111542340eCement Try-In Paste Translucent 2g Syringe
00810111542326eCement Try-In Paste A1 2g Syringe

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