GentleCLEAN™ DSG30GCP

GUDID 00810000522729

Pink Soft-Grip 30k GentleCLEAN™ Ultrasonic Scaler Insert

PARKELL, INC.

Ultrasonic dental scaling/debridement system handpiece tip, periodontal

• Primary Device ID: 00810000522729
• NIH Device Record Key: 1b41faa0-98eb-47fe-92ab-9a65fc5e9e3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GentleCLEAN™
• Version Model Number: DSG30GCP
• Catalog Number: DSG30GCP
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000522729 [Primary]

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

[00810000522729]

Moist Heat or Steam Sterilization

[00810000522729]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-03
• Device Publish Date: 2018-11-02

On-Brand Devices [GentleCLEAN™]

• 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.)