Accessory

Basic Information

• Brand Name: Accessory
• Primary DI: 10810111542705
• Version / Model: X-80497P
• Catalog Number: X-80497P
• Company Name: BISCO INC.
• Labeler DUNS: 053529939
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 48
• Record Status: Published
• Publish Date: 2022-11-21
• Public Version: 2
• Public Version Date: 2023-05-04
• Public Version Status: Update
• Public Device Record Key: 6eba6d7c-b0c8-415c-b719-dbbf8989c1c8

Device Description

Disposable Mixing Wells - Single Well, 48pk

Device Characteristics

• Single Use: Yes
• 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
KXR	APPLICATOR, RESIN	Dental	872.3140	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44999	Dental material mixing surface, chairside, single-use	A pad, tray, well, or palette with wells intended to be used as a surface for mixing inactive dental component materials chairside to produce a functional dental restorative/impression material that is immediately applied to the oral cavity/teeth of the patient, or extraorally to a dental restoration, during a dental procedure. It is typically made of plastic and the user will ordinarily mix the component materials on or in the device by hand (e.g., with a spatula or brush). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00810111542708	GS1
Primary	10810111542705	GS1
Previous	D757X80497P1	HIBCC

Customer Contacts

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