Grafco

Basic Information

• Brand Name: Grafco
• Primary DI: M368339511
• Version / Model: 3395-1
• Catalog Number: 3395-1
• Company Name: GF HEALTH PRODUCTS, INC.
• Labeler DUNS: 132016168
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 144
• Record Status: Published
• Publish Date: 2021-06-08
• Public Version: 1
• Public Version Date: 2021-06-16
• Public Version Status: New
• Public Device Record Key: a9ec8772-fdd5-4920-b649-1d7471c2ce86

Device Description

TOOTHBRUSH ADULT 39TUFT 144/C

Device Characteristics

• Single Use: No
• 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: 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
EFW	Toothbrush, Manual	Dental	872.6855	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31817	Basic manual toothbrush	An instrument designed to be used by a patient to manually brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device is typically used with toothpaste. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	M368339510	HIBCC
Primary	M368339511	HIBCC

Customer Contacts

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