REFINE

GUDID 06971560454333

Guilin Refine Medical Instrument Co.,LTD.

Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp

• Primary Device ID: 06971560454333
• NIH Device Record Key: 10e7a7f2-4fa5-4080-8422-ec732f201ba3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REFINE
• Version Model Number: SWAN+
• Company DUNS: 407578472
• Company Name: Guilin Refine 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971560454333 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223414

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: 2023-12-05
• Device Publish Date: 2023-11-27

On-Brand Devices [REFINE]

• 06971560453459: Dentifrice
• 06971560453428: Endodontic obturation system
• 06971560453411: Endodontic obturation system
• 06971560450878: Eye splash shield
• 06971560450786: MaxCure9
• 06971560454333: SWAN+
• 06971560452575: VAT-3
• 06971560450175: SWAN
• 06971560450052: A-Cure Plus
• 06971560450045: A-Cure
• 06971560454234: MaxCureG
• 06971560453190: MaxCureH
• 06971560453145: MaxCure5
• 06971560452698: MaxCure3