DBA

GUDID 06944843601755

Ultrasonic Scalers

Guilin Woodpecker Medical Instrument Co., Ltd.

Ultrasonic dental scaling/debridement system

• Primary Device ID: 06944843601755
• NIH Device Record Key: 559e4cf2-b944-4099-aa6e-5bcdd752c9e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DBA
• Version Model Number: D3
• Company DUNS: 545272577
• Company Name: Guilin Woodpecker Medical Instrument Co., Ltd.
• 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944843601755 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053555

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

[06944843601755]

Moist Heat or Steam Sterilization

[06944843601755]

Moist Heat or Steam Sterilization

[06944843601755]

Moist Heat or Steam Sterilization

[06944843601755]

Moist Heat or Steam Sterilization

[06944843601755]

Moist Heat or Steam Sterilization

[06944843601755]

Moist Heat or Steam Sterilization

[06944843601755]

Moist Heat or Steam Sterilization

[06944843601755]

Moist Heat or Steam Sterilization

[06944843601755]

Moist Heat or Steam Sterilization

[06944843601755]

Moist Heat or Steam Sterilization

[06944843601755]

Moist Heat or Steam Sterilization

[06944843601755]

Moist Heat or Steam Sterilization

[06944843601755]

Moist Heat or Steam Sterilization

[06944843601755]

Moist Heat or Steam Sterilization

[06944843601755]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-10-20

On-Brand Devices [DBA]

• 06944843602417: Curing Light
• 06944843601762: Ultrasonic Scalers
• 06944843601755: Ultrasonic Scalers
• 06944843605166: Ultrasonic dental scaling/debridement system
• 06944843611488: Dental delivery system instrument unit, electric
• 06944843611310: Gutta-percha injector
• 06944843611303: Gutta-percha injector
• 06944843611242: Dental digital imaging sensor, intraoral
• 06944843611099: Dental digital imaging sensor, intraoral