DTE,WOODPECKER

GUDID 06944843605494

Ultrasonic dental scaling/debridement system

Guilin Woodpecker Medical Instrument Co., Ltd.

Ultrasonic dental scaling/debridement system

• Primary Device ID: 06944843605494
• NIH Device Record Key: 5933585b-f77c-4920-87ad-2432ffbc693e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DTE,WOODPECKER
• Version Model Number: ED98
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944843605494 [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

[06944843605494]

Moist Heat or Steam Sterilization

[06944843605494]

Moist Heat or Steam Sterilization

[06944843605494]

Moist Heat or Steam Sterilization

[06944843605494]

Moist Heat or Steam Sterilization

[06944843605494]

Moist Heat or Steam Sterilization

[06944843605494]

Moist Heat or Steam Sterilization

[06944843605494]

Moist Heat or Steam Sterilization

[06944843605494]

Moist Heat or Steam Sterilization

[06944843605494]

Moist Heat or Steam Sterilization

[06944843605494]

Moist Heat or Steam Sterilization

[06944843605494]

Moist Heat or Steam Sterilization

[06944843605494]

Moist Heat or Steam Sterilization

[06944843605494]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-29
• Device Publish Date: 2022-08-19

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