Parkell®

Basic Information

• Brand Name: Parkell®
• Primary DI: 10810000522054
• Version / Model: D410
• Catalog Number: D419
• Company Name: PARKELL, INC.
• Labeler DUNS: 009900424
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2018-09-14
• Public Version: 2
• Public Version Date: 2022-07-21
• Public Version Status: Update
• Public Device Record Key: ad7c002b-2f99-4753-b989-5909c4cfee1a

Device Description

Replacement Water Filter Disks (Pkg. of 10 Disks) for all Scalers & Irrigators

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: No
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ELC	Scaler, Ultrasonic	Dental	872.4850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35433	Particulate water purification filter	A device designed to remove sediment and other suspended particles from flowing water by creating a mechanical barrier to elements larger than a specified size (e.g., 5 to 10 microns/micrometres); it is often made of polypropylene filaments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10810000522054	GS1
Unit of Use	00810000522057	GS1

Customer Contacts

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