WOODEPCKER

GUDID 06944843609249

Ultrasonic dental scaling/debridement system handpiece tip, endodontic

Guilin Woodpecker Medical Instrument Co., Ltd.

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• Primary Device ID: 06944843609249
• NIH Device Record Key: 42913686-8c0a-4943-8e68-4bcb0564bdb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WOODEPCKER
• Version Model Number: GD32
• 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	06944843609249 [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

[06944843609249]

Moist Heat or Steam Sterilization

[06944843609249]

Moist Heat or Steam Sterilization

[06944843609249]

Moist Heat or Steam Sterilization

[06944843609249]

Moist Heat or Steam Sterilization

[06944843609249]

Moist Heat or Steam Sterilization

[06944843609249]

Moist Heat or Steam Sterilization

[06944843609249]

Moist Heat or Steam Sterilization

[06944843609249]

Moist Heat or Steam Sterilization

[06944843609249]

Moist Heat or Steam Sterilization

[06944843609249]

Moist Heat or Steam Sterilization

[06944843609249]

Moist Heat or Steam Sterilization

[06944843609249]

Moist Heat or Steam Sterilization

[06944843609249]

Moist Heat or Steam Sterilization

[06944843609249]

Moist Heat or Steam Sterilization

[06944843609249]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-21
• Device Publish Date: 2017-10-21

Devices Manufactured by Guilin Woodpecker Medical Instrument Co., Ltd.

• 06944843605326 - DTE,WOODPECKER: 2022-08-29 Ultrasonic dental scaling/debridement system
• 06944843605333 - DTE,WOODPECKER: 2022-08-29 Ultrasonic dental scaling/debridement system
• 06944843605340 - DTE,WOODPECKER: 2022-08-29 Ultrasonic dental scaling/debridement system
• 06944843605357 - DTE,WOODPECKER: 2022-08-29 Ultrasonic dental scaling/debridement system
• 06944843605364 - DTE,WOODPECKER: 2022-08-29 Ultrasonic dental scaling/debridement system
• 06944843605418 - DTE,WOODPECKER: 2022-08-29 Ultrasonic dental scaling/debridement system
• 06944843605449 - DTE,WOODPECKER: 2022-08-29 Ultrasonic dental scaling/debridement system
• 06944843605456 - DTE,WOODPECKER: 2022-08-29 Ultrasonic dental scaling/debridement system