LOVE HYGIENE

GUDID 06944843616872

Dental Scaler and Air Polisher

Guilin Woodpecker Medical Instrument Co., Ltd.

Ultrasonic dental scaling/debridement system

• Primary Device ID: 06944843616872
• NIH Device Record Key: 66164d0c-0069-4c8c-801f-617e960ae5d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOVE HYGIENE
• Version Model Number: Love Hygiene Air
• 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: true
• 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	06944843616872 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203615

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

[06944843616872]

Moist Heat or Steam Sterilization

[06944843616872]

Moist Heat or Steam Sterilization

[06944843616872]

Moist Heat or Steam Sterilization

[06944843616872]

Moist Heat or Steam Sterilization

[06944843616872]

Moist Heat or Steam Sterilization

[06944843616872]

Moist Heat or Steam Sterilization

[06944843616872]

Moist Heat or Steam Sterilization

[06944843616872]

Moist Heat or Steam Sterilization

[06944843616872]

Moist Heat or Steam Sterilization

[06944843616872]

Moist Heat or Steam Sterilization

[06944843616872]

Moist Heat or Steam Sterilization

[06944843616872]

Moist Heat or Steam Sterilization

[06944843616872]

Moist Heat or Steam Sterilization

[06944843616872]

Moist Heat or Steam Sterilization

[06944843616872]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-19
• Device Publish Date: 2024-08-09

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

• 06944843605982 - woodpecker: 2024-10-28 Cordless Prophy System
• 06944843611587 - woodpecker: 2024-10-28 Dental Air Polisher
• 06944843611594 - DTE: 2024-10-28 Dental Air Polisher
• 06944843611600 - woodpecker: 2024-10-28 Dental Scaler and Air Polisher
• 06944843611617 - DTE: 2024-10-28 Dental Scaler and Air Polisher
• 06944843617510 - DTE: 2024-10-28 Ultrasonic Scaler
• 06944843655987 - DTE: 2024-10-28 Dental Scaler and Air Polisher
• 06944843657721 - DTE: 2024-10-28 Cordless Prophy System