DTE

GUDID 06944843601823

Ultrasonic Scalers

Guilin Woodpecker Medical Instrument Co., Ltd.

Ultrasonic dental scaling/debridement system

• Primary Device ID: 06944843601823
• NIH Device Record Key: 8fb24059-f187-49fa-b94c-6c4ddd0f715f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DTE
• Version Model Number: V6 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: 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	06944843601823 [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

[06944843601823]

Moist Heat or Steam Sterilization

[06944843601823]

Moist Heat or Steam Sterilization

[06944843601823]

Moist Heat or Steam Sterilization

[06944843601823]

Moist Heat or Steam Sterilization

[06944843601823]

Moist Heat or Steam Sterilization

[06944843601823]

Moist Heat or Steam Sterilization

[06944843601823]

Moist Heat or Steam Sterilization

[06944843601823]

Moist Heat or Steam Sterilization

[06944843601823]

Moist Heat or Steam Sterilization

[06944843601823]

Moist Heat or Steam Sterilization

[06944843601823]

Moist Heat or Steam Sterilization

[06944843601823]

Moist Heat or Steam Sterilization

[06944843601823]

Moist Heat or Steam Sterilization

[06944843601823]

Moist Heat or Steam Sterilization

[06944843601823]

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 [DTE]

• 06944843610023: Ultrasonic Periodontal Treatment Device
• 06944843607221: Ultrasonic dental scaling/debridement system handpiece
• 06944843607214: Ultrasonic dental scaling/debridement system handpiece
• 06944843607108: Ultrasonic dental scaling/debridement system handpiece
• 06944843607092: Ultrasonic dental scaling/debridement system handpiece
• 06944843606316: Ultrasonic dental scaling/debridement system handpiece tip, periodontal
• 06944843606231: Ultrasonic dental scaling/debridement system handpiece tip, periodontal
• 06944843606217: Ultrasonic dental scaling/debridement system handpiece tip, periodontal
• 06944843605074: Piezo Bone Surgery
• 06944843605050: Piezo Bone Surgery
• 06944843605043: ULTRASURGERY
• 06944843603094: Ultrasonic Scalers
• 06944843603087: Ultrasonic Scalers
• 06944843602424: Curing Light
• 06944843602332: Dental Curing Light
• 06944843602271: Dental Curing Light
• 06944843602264: Curing Light
• 06944843602257: Dental Curing Light
• 06944843602240: Curing Light
• 06944843602233: Dental Curing Light
• 06944843602226: Curing Light
• 06944843602219: Dental Curing Light
• 06944843602202: Curing Light
• 06944843602196: Curing Light
• 06944843602189: Curing Light
• 06944843601984: Dental Ultrasonic Scaler
• 06944843601823: Ultrasonic Scalers
• 06944843601649: Dental Ultrasonic Scaler
• 06944843601632: Ultrasonic Scalers
• 06944843601519: Ultrasonic Scalers
• 06944843601496: Ultrasonic Scalers
• 06944843601168: Dental Ultrasonic Scaler
• 06944843601151: Ultrasonic Scalers
• 06944843601144: Dental Ultrasonic Scaler
• 06944843601137: Ultrasonic Scalers
• 06944843601120: Dental Ultrasonic Scaler
• 06944843601113: Ultrasonic Scalers
• 06944843601106: Dental Ultrasonic Scaler
• 06944843601090: Ultrasonic Scalers
• 06944843601083: Dental Ultrasonic Scaler
• 06944843601076: Ultrasonic Scalers
• 06944843601069: Dental Ultrasonic Scaler
• 06944843601052: Ultrasonic Scalers
• 06944843601045: Dental Ultrasonic Scaler
• 06944843601038: Ultrasonic Scalers
• 06944843601021: Dental Ultrasonic Scaler
• 06944843601014: Ultrasonic Scalers
• 06944843600864: Tips of Ultrasonic Scalers
• 06944843600857: Tips of Ultrasonic Scalers
• 06944843600840: Tips of Ultrasonic Scalers