22G Black 50eaPkg w/Label X-80621N

GUDID D757X80621N1

BISCO INC.

Dental material injection cannula, single-use
Primary Device IDD757X80621N1
NIH Device Record Key5220070f-9125-4b5d-8a75-2e12f2401bc6
Commercial Distribution Discontinuation2022-11-21
Commercial Distribution StatusNot in Commercial Distribution
Brand Name22G Black 50eaPkg w/Label
Version Model NumberX-80621N
Catalog NumberX-80621N
Company DUNS053529939
Company NameBISCO 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 Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD757X80621N1 [Primary]

FDA Product Code

EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-11-22
Device Publish Date2018-11-06

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D757B36050 - Ace All-Bond TE Cartrdg(Pouch)2024-02-16
D757B36050P1 - Ace All-Bond TE 4 Cartrdg Pkg2024-02-16
D757B3605PS1 - ACE-All-Bond TE 1 CartridgePkg2024-02-16
D757B36100K1 - ACE All-Bond TE Starter Kit2024-02-16
D757B412010 - Ace Universal Primer A&B Cartridge-Pouch2024-02-16

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