PerioSonic® D584

GUDID 00810000520343

Model-W PerioSonic® Multi-Fluid Irrigator

PARKELL, INC.

Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system

• Primary Device ID: 00810000520343
• NIH Device Record Key: 5c396bb1-7cc9-40eb-b918-724f2da2af86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PerioSonic®
• Version Model Number: D584
• Catalog Number: D584
• Company DUNS: 009900424
• Company Name: PARKELL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000520343 [Primary]

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-17
• Device Publish Date: 2018-11-16

On-Brand Devices [PerioSonic®]

• 00810000520343: Model-W PerioSonic® Multi-Fluid Irrigator
• 00810000520336: PerioSonic® Multi-Fluid Irrigator Basic
• M595D5840: Model-W PerioSonic Multi-Fluid Irrigator
• M595D5830: PerioSonic Multi-Fluid Irrigator Basic
• M595D5811: Empty Bottles for PerioSonic Irrigator D583 & D584 (6 Bottles & Caps)
• 10810000520326: Empty Bottles for PerioSonic® Irrigator D583 & D584 (6 Bottles & Caps)