DBA

GUDID 06944843611242

Dental digital imaging sensor, intraoral

Guilin Woodpecker Medical Instrument Co., Ltd.

Dental digital imaging sensor, intraoral

• Primary Device ID: 06944843611242
• NIH Device Record Key: f44f0b99-9fe9-45e0-86db-91350ada4e7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DBA
• Version Model Number: i-Sensor H1
• 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	06944843611242 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212279

FDA Product Code

• MUH: System, X-Ray, Extraoral Source, Digital

Sterilization

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

[06944843611242]

Moist Heat or Steam Sterilization

[06944843611242]

Moist Heat or Steam Sterilization

[06944843611242]

Moist Heat or Steam Sterilization

[06944843611242]

Moist Heat or Steam Sterilization

[06944843611242]

Moist Heat or Steam Sterilization

[06944843611242]

Moist Heat or Steam Sterilization

[06944843611242]

Moist Heat or Steam Sterilization

[06944843611242]

Moist Heat or Steam Sterilization

[06944843611242]

Moist Heat or Steam Sterilization

[06944843611242]

Moist Heat or Steam Sterilization

[06944843611242]

Moist Heat or Steam Sterilization

[06944843611242]

Moist Heat or Steam Sterilization

[06944843611242]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-23
• Device Publish Date: 2022-08-15

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• 06944843601755: Ultrasonic Scalers
• 06944843605166: Ultrasonic dental scaling/debridement system
• 06944843611488: Dental delivery system instrument unit, electric
• 06944843611310: Gutta-percha injector
• 06944843611303: Gutta-percha injector
• 06944843611242: Dental digital imaging sensor, intraoral
• 06944843611099: Dental digital imaging sensor, intraoral