Dr's Light2

GUDID 18800025400101

ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

GOOD DOCTORS CO., LTD.

Dental/surgical polymerization lamp

• Primary Device ID: 18800025400101
• NIH Device Record Key: f9086995-5685-4196-b51d-821ef77615ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dr's Light2
• Version Model Number: CL-DLT30
• Company DUNS: 688201036
• Company Name: GOOD DOCTORS 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800025400104 [Primary]
GS1	18800025400101 [Package]; Contains: 08800025400104; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173157

FDA Product Code

• EBZ: Activator, Ultraviolet, For Polymerization

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: 2019-11-07
• Device Publish Date: 2019-10-30