22G Black Tip, 15ea/Bag X-80622N

GUDID D757X80622N1

BISCO INC.

Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use

• Primary Device ID: D757X80622N1
• NIH Device Record Key: d4c0352d-a399-440f-a9bb-d61f288e39da
• Commercial Distribution Discontinuation: 2022-11-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: 22G Black Tip, 15ea/Bag
• Version Model Number: X-80622N
• Catalog Number: X-80622N
• Company DUNS: 053529939
• Company Name: BISCO INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D757X80622N1 [Primary]

FDA Product Code

• EID: SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-11-22
• Device Publish Date: 2018-11-06

Devices Manufactured by BISCO INC.

• 00810111542937 - TheraCal PT: 2024-04-11 TheraCal PT 2g Dual Syr
• 00810111542944 - TheraCal PT: 2024-04-11 TheraCal PT 2g Syr Pkg
• D757B2501A1 - PRE-BOND Resin 3ml Btl: 2024-02-16
• D757B36050 - Ace All-Bond TE Cartrdg(Pouch): 2024-02-16
• D757B36050P1 - Ace All-Bond TE 4 Cartrdg Pkg: 2024-02-16
• D757B3605PS1 - ACE-All-Bond TE 1 CartridgePkg: 2024-02-16
• D757B36100K1 - ACE All-Bond TE Starter Kit: 2024-02-16
• D757B412010 - Ace Universal Primer A&B Cartridge-Pouch: 2024-02-16