LUVIS-C400 Series

GUDID 08800053083904

AC 12-18 V, 2.0 A, 50/60 Hz

DENTIS CO. ,LTD

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• Primary Device ID: 08800053083904
• NIH Device Record Key: 77b9c3f8-db34-4223-a343-c643bc0667e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUVIS-C400 Series
• Version Model Number: C400 HEAD
• Company DUNS: 694721181
• Company Name: DENTIS CO. ,LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800053083904 [Primary]

FDA Product Code

• EAZ: Light, Operating, Dental

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-31
• Device Publish Date: 2024-01-23

On-Brand Devices [LUVIS-C400 Series]

• 08800053083935: AC 100-240 V~ 1.5 A, 50-60 Hz
• 08800053083928: AC 100-240 V, 1.5 A, 50-60 Hz
• 08800053083911: AC 12-18 V, 2.0 A, 50/60 Hz AC 100-240 V, 1.5 A, 50-60 Hz
• 08800053083904: AC 12-18 V, 2.0 A, 50/60 Hz