ZirClean B-7351P

GUDID 00810111542487

ZIRCLEAN - 5 gram SYRINGE Pkg

BISCO INC.

Dental restoration fixation cleaning solution
Primary Device ID00810111542487
NIH Device Record Keya3e4114f-2efd-4d85-84a9-f9d4e47526ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameZirClean
Version Model NumberB-7351P
Catalog NumberB-7351P
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 Datetrue
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810111542487 [Primary]
HIBCCD757B7351P1 [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 Date2022-08-08
Device Publish Date2022-07-29

On-Brand Devices [ZirClean]

D757B7351P1ZIRCLEAN - 5 gram SYRINGE Pkg
D757B73510ZIRCLEAN - 5 gram SYRINGE
00810111542487ZIRCLEAN - 5 gram SYRINGE Pkg
00810111542470ZIRCLEAN - 5 gram SYRINGE

Trademark Results [ZirClean]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ZIRCLEAN
ZIRCLEAN
87537242 5638925 Live/Registered
Bisco Inc.
2017-07-21
ZIRCLEAN
ZIRCLEAN
73596853 1417141 Dead/Cancelled
E. I. DU PONT DE NEMOURS AND COMPANY
1986-05-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.