LUXITE luxite-U

GUDID 03760260224000

ITENA CLINICAL

Dental/surgical polymerization lamp

• Primary Device ID: 03760260224000
• NIH Device Record Key: 1c4fc3b5-41c8-4707-8379-08ba3b07876a
• Commercial Distribution Discontinuation: 2021-04-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: LUXITE
• Version Model Number: luxite unit
• Catalog Number: luxite-U
• Company DUNS: 262150858
• Company Name: ITENA CLINICAL
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760260224000 [Primary]

FDA Product Code

• EBZ: Activator, Ultraviolet, For Polymerization

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-10-19
• Device Publish Date: 2016-10-15

Devices Manufactured by ITENA CLINICAL

• 03760260220385 - MTA BIOREP: 2022-12-01
• 03760260220392 - MTA BIOREP: 2022-12-01
• 03760260220408 - MTA BIOSEAL: 2022-12-01
• 03760260220002 - REFLECTYS: 2022-11-10
• 03760260220019 - REFLECTYS: 2022-11-10
• 03760260220026 - REFLECTYS: 2022-11-10
• 03760260220033 - REFLECTYS: 2022-11-10
• 03760260220040 - REFLECTYS: 2022-11-10