PerioSonic® D581
GUDID 10810000520326
Empty Bottles for PerioSonic® Irrigator D583 & D584 (6 Bottles & Caps)
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 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 | 10810000520326 |
| NIH Device Record Key | 5bc64ad6-fc49-4a69-976f-5b8799e99029 |
| Commercial Distribution Discontinuation | 2023-01-20 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | PerioSonic® |
| Version Model Number | D581 |
| Catalog Number | D581 |
| Company DUNS | 009900424 |
| Company Name | PARKELL, INC. |
| Device Count | 6 |
| 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 | false |
| Manufacturing Date | false |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810000520329 [Unit of Use] |
| GS1 | 10810000520326 [Primary] |
FDA Product Code
| ELC | Scaler, Ultrasonic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-04-13 |
| 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) |
Trademark Results [PerioSonic]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PERIOSONIC 75064520 2075288 Live/Registered |
PARKELL INC. 1996-02-27 |
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