| Primary Device ID | M595DSG30GCW0 |
| NIH Device Record Key | a0328fd9-3386-47db-a3b4-a92aac6da3d5 |
| Commercial Distribution Discontinuation | 2019-01-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | GentleCLEAN™ |
| Version Model Number | DSG30GCW |
| Catalog Number | DSG30GCW |
| 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 | true |
| 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 |
| Phone | 6312491134 |
| customerservice@parkell.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M595DSG30GCW0 [Primary] |
| ELC | Scaler, Ultrasonic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M595DSG30GCW0]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-04-01 |
| Device Publish Date | 2016-09-23 |
| 00810000522750 | Wrench for Attaching GentleCLEAN™ Tips |
| 00810000522729 | Pink Soft-Grip 30k GentleCLEAN™ Ultrasonic Scaler Insert |
| 00810000522712 | GentleCLEAN™ 30khz Soft-Grip Insert |
| M595DSG30GCW0 | Wrench for Attaching GentleCLEAN™ Tips |
| M595DSG30GCT1 | Tips for GentleCLEAN™ Insert (Pkg. of 50 pcs.) |
| M595DSG30GCP0 | Pink Soft-Grip 30k GentleCLEAN™ Ultrasonic Scaler Insert |
| M595DSG30GC0 | GentleCLEAN™ 30khz Soft-Grip Insert |
| 10810000522733 | Tips for GentleCLEAN™ Insert (Pkg. of 50 pcs.) |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GENTLECLEAN 90539241 not registered Live/Pending |
GENTLECLEAN 2021-02-22 |
![]() GENTLECLEAN 88287092 not registered Live/Pending |
KD Skincare LLC 2019-02-03 |
![]() GENTLECLEAN 78684840 3259375 Dead/Cancelled |
General Electric Company 2005-08-03 |