Henry Schein

Basic Information

• Brand Name: Henry Schein
• Primary DI: 00304040186497
• Version / Model: 5703899
• Catalog Number: 5703899
• Company Name: HENRY SCHEIN, INC.
• Labeler DUNS: 012430880
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-18
• Public Version: 1
• Public Version Date: 2024-09-26
• Public Version Status: New
• Public Device Record Key: 4ef0ea5f-a1a4-4f38-bb10-b8f5d6fff662

Device Description

ACCLEAN Hands-free HVE Standard Kit (2 Long Hoses, 6 Short Hoses with Adapters, 100 Leaves, 5 mini leaves, IFU)

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: 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
EHZ	Evacuator, oral cavity	Dental	872.6640	1
DYN	Mouthpiece, saliva ejector	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66751	Dental suction protective mouthpiece	A prefabricated device designed to be placed in the oral cavity during a dental procedure to protect the oral pathway by serving as a conduit for the continuous suction of debris/saliva, shielding the oral anatomy, maintaining an open mouth and retracted cheeks, and depressing the tongue. It is made of preformed materials for direct insertion into the mouth and includes features for connection to a dental suction unit. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00304040186497	GS1