SmileGoods Floss Dispenser Refill Unwaxed

Basic Information

• Brand Name: SmileGoods Floss Dispenser Refill Unwaxed
• Primary DI: 00723896002490
• Version / Model: 840D/80T UNWAXED
• Catalog Number: 70-452102
• Company Name: PRACTICON, INC.
• Labeler DUNS: 119193803
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-18
• Public Version: 1
• Public Version Date: 2018-08-20
• Public Version Status: New
• Public Device Record Key: 0547d8bd-2dcb-4423-8a0a-dfc729c3b5ce

Device Description

shred-resistant nylon floss and smooth cores that fit inside dispensers more securely. 200 yards

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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
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	00723896010426	GS1	Case	4	In Commercial Distribution
Package	00723896010419	GS1	Inner Pack	50	In Commercial Distribution
Primary	00723896002490	GS1