BISICO Dispenser 25

Basic Information

• Brand Name: BISICO Dispenser 25
• Primary DI: EBIB019401
• Version / Model: 01940
• Catalog Number: 01940
• Company Name: bisico Bielefelder Dentalsilicone GmbH & Co. KG
• Labeler DUNS: 316133664
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-28
• Public Version: 1
• Public Version Date: 2023-07-06
• Public Version Status: New
• Public Device Record Key: 41935124-5b28-442b-9fa8-418f6c8c24e9

Device Description

A non-sterile hand-held manual dental instrument designed to inject impression material into an impression tray or directly into a patient's mouth.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EID	Syringe, Restorative And Impression Material	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35860	Dental impression material syringe, reusable	A non-sterile hand-held manual dental instrument designed to inject impression material into an impression tray or directly into a patient's mouth. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EBIB019401	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]