DTE

GUDID 06944843602196

Curing Light

Guilin Woodpecker Medical Instrument Co., Ltd.

Dental/surgical polymerization lamp

• Primary Device ID: 06944843602196
• NIH Device Record Key: fe4e5749-8bee-4064-956f-468481917fd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DTE
• Version Model Number: LUX E PLUS
• 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	06944843602196 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080025

FDA Product Code

• EBZ: Activator, Ultraviolet, For Polymerization

Sterilization

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

[06944843602196]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-20

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