Simple Line

Basic Information

• Brand Name: Simple Line
• Primary DI: 08809162706391
• Version / Model: SOXHD21W
• Catalog Number: SOXHD21W
• Company Name: Dentium Co., Ltd.
• Labeler DUNS: 689514395
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-14
• Public Version: 2
• Public Version Date: 2020-07-07
• Public Version Status: Update
• Public Device Record Key: 5371f76b-c4c1-4cfb-9d1e-622c7d866400

Device Description

Driver, Band, Orthodontic

Device Characteristics

• Single Use: No
• 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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ECT	DRIVER, BAND, ORTHODONTIC	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64304	Manual non-rotary dental instrument handle	A hand-held, manual device designed to hold and facilitate manipulation of a non-powered, non-rotary dental instrument (e.g., endodontic file/rasp, implant extractor). It is designed to accept the patient-contact endpiece (not included) for ease of handling. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809162706391	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	21	Millimeter