DermoSight Dermatoscope DXH-HW-100

GUDID 00860013961404

Handheld optical skin imaging device

DEEPX HEALTH, LLC

Dermatoscope, optical

• Primary Device ID: 00860013961404
• NIH Device Record Key: f263b9f4-1ab8-4df2-9f7e-a063fd460a0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DermoSight Dermatoscope
• Version Model Number: DXH-HW-100
• Catalog Number: DXH-HW-100
• Company DUNS: 118742338
• Company Name: DEEPX HEALTH, LLC
• 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: true
• 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	00860013961404 [Primary]

FDA Product Code

• PSN: Light Based Imaging

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: 2025-06-27
• Device Publish Date: 2025-06-19

Devices Manufactured by DEEPX HEALTH, LLC

• 00860013961404 - DermoSight Dermatoscope: 2025-06-27Handheld optical skin imaging device
• 00860013961404 - DermoSight Dermatoscope: 2025-06-27 Handheld optical skin imaging device
• 00860013961411 - DermoSight Software: 2025-06-27 Web-based software for dermatoscope image capture and analysis