Focus Medical

GUDID 00865601000343

FOCUS MEDICAL, LLC

Multi-modality skin surface treatment system

• Primary Device ID: 00865601000343
• NIH Device Record Key: f0e90e6a-9974-4d3e-adc4-717977b1a0c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Focus Medical
• Version Model Number: Erbium Laser
• Company DUNS: 841432912
• Company Name: FOCUS MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• 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	00865601000343 [Primary]

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2018-12-31
• Device Publish Date: 2018-11-30

On-Brand Devices [Focus Medical]

• 00865601000343: Erbium Laser
• 00865601000336: CO2 Laser
• 00865601000312: NaturaLaseQS
• 00865601000350: IPL