Henry Schein

Basic Information

• Brand Name: Henry Schein
• Primary DI: 10304040036690
• Version / Model: 1552880
• Catalog Number: 1552880
• Company Name: HENRY SCHEIN, INC.
• Labeler DUNS: 012430880
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2019-01-25
• Public Version: 1
• Public Version Date: 2019-02-25
• Public Version Status: New
• Public Device Record Key: 9a641444-e175-4f99-980b-0cc0869bdd23

Device Description

Dental Floss

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: 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
JES	FLOSS, DENTAL	Dental	872.6390	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11158	Dental floss	A string-like device formed as thread or tape, used for the removal of plaque and/or debris from the proximal surfaces of teeth and the gingival surfaces of fixed prostheses. It is typically made of a synthetic fibre. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20304040036697	GS1	CASE	6	In Commercial Distribution
Primary	10304040036690	GS1
Unit of Use	00304040036693	GS1

Device Sizes

Type	Value	Unit	Text
Length	200	Yard

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Storage Environment Temperature