WOODPECKER,DTE

GUDID 06944843601724

Dental ultrasonic surgical system

Guilin Woodpecker Medical Instrument Co., Ltd.

Ultrasonic dental scaling/debridement system

• Primary Device ID: 06944843601724
• NIH Device Record Key: c493fc5f-1f66-47db-b71a-2ed7c446f353
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WOODPECKER,DTE
• Version Model Number: Marathon LED
• 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944843601724 [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

[06944843601724]

Moist Heat or Steam Sterilization

[06944843601724]

Moist Heat or Steam Sterilization

[06944843601724]

Moist Heat or Steam Sterilization

[06944843601724]

Moist Heat or Steam Sterilization

[06944843601724]

Moist Heat or Steam Sterilization

[06944843601724]

Moist Heat or Steam Sterilization

[06944843601724]

Moist Heat or Steam Sterilization

[06944843601724]

Moist Heat or Steam Sterilization

[06944843601724]

Moist Heat or Steam Sterilization

[06944843601724]

Moist Heat or Steam Sterilization

[06944843601724]

Moist Heat or Steam Sterilization

[06944843601724]

Moist Heat or Steam Sterilization

[06944843601724]

Moist Heat or Steam Sterilization

[06944843601724]

Moist Heat or Steam Sterilization

[06944843601724]

Moist Heat or Steam Sterilization

[06944843601724]

Moist Heat or Steam Sterilization

[06944843601724]

Moist Heat or Steam Sterilization

[06944843601724]

Moist Heat or Steam Sterilization

[06944843601724]

Moist Heat or Steam Sterilization

[06944843601724]

Moist Heat or Steam Sterilization

[06944843601724]

Moist Heat or Steam Sterilization

[06944843601724]

Moist Heat or Steam Sterilization

[06944843601724]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-27
• Device Publish Date: 2021-08-19

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• 06944843603063: Apex locator, endodontic
• 06944843603056: Apex locator, endodontic
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• 06944843603032: Apex locator, endodontic
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• 06944843604602: Ultrasonic dental scaling/debridement system handpiece tip, periodontal
• 06944843604596: Ultrasonic dental scaling/debridement system handpiece tip, periodontal
• 06944843604589: Ultrasonic dental scaling/debridement system handpiece tip, endodontic
• 06944843604572: Ultrasonic dental scaling/debridement system handpiece tip, periodontal
• 06944843604565: Ultrasonic dental scaling/debridement system