Henry Schein

Basic Information

• Brand Name: Henry Schein
• Primary DI: H65810183591
• Version / Model: 1018359
• Catalog Number: 1018359
• Company Name: HENRY SCHEIN, INC.
• Labeler DUNS: 012430880
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2020-06-17
• Public Version: 1
• Public Version Date: 2020-06-25
• Public Version Status: New
• Public Device Record Key: fe97864a-516b-4b5c-81ca-7e868c3f4424

Device Description

Blu-Bite Ribbon Tips

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
62682	Dental impression material kit, reusable	A collection of non-sterile devices designed to obtain a negative imprint of the teeth and/or upper palate (i.e., the roof of the mouth with the gums and teeth). It is subsequently used to make a mould for the manufacture of a custom-made dental prosthesis, orthodontic appliance, and/or oral appliance. The kit typically includes dental impression materials and reusable application devices (e.g., cartridge gun), and might include a dental impression tray(s). Impression material is placed on the tray and the tray is then positioned in the mouth of the patient until the material becomes firm creating the mould. This is a reusable device that may contain some disposable devices.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	H65810183592	HIBCC		50	In Commercial Distribution
Primary	H65810183591	HIBCC
Unit of Use	H65810183599	HIBCC