PREPSTART

Basic Information

• Brand Name: PREPSTART
• Primary DI: 00816594021785
• Version / Model: 200259-00
• Catalog Number: 200259-00
• Company Name: DANVILLE MATERIALS, LLC
• Labeler DUNS: 601302743
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-22
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 2a17cca9-ce03-46e4-a844-6883278832eb

Device Description

PREPSTART

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KOJ	AIRBRUSH	Dental	872.6080	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45404	Dental abrasive air jet system control unit	A device that is a component of a dental abrasive air jet system and that is used to control and regulate the supply of air and water that is fed through the dedicated handpiece together with an abrasive powder giving a concise jet that impacts the surface of the teeth being treated. The dentist will typically regulate the air/water supply through controls on the front panel whilst a foot-switch controls the abrasion process. Pressurized air from a standard air compressor and temperate water are connected to this device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816594021785	GS1

Customer Contacts

• Phone: [phone] ext. 145
• Email: [email protected]