DELTAone K-214.28.305

GUDID 04053755202928

Heine Optotechnik GmbH & Co. KG

Dermatoscope, optical

• Primary Device ID: 04053755202928
• NIH Device Record Key: 733beed4-255e-4675-bad3-ed36d3595c56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DELTAone
• Version Model Number: BLACK WHITE EDITION
• Catalog Number: K-214.28.305
• Company DUNS: 315274563
• Company Name: Heine Optotechnik GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Customer Support Contacts

• Phone: +4908152380
• Email: info@heine.com
• Phone: +4908152380
• Email: info@heine.com
• Phone: +4908152380
• Email: info@heine.com
• Phone: +4908152380
• Email: info@heine.com
• Phone: +4908152380
• Email: info@heine.com
• Phone: +4908152380
• Email: info@heine.com
• Phone: +4908152380
• Email: info@heine.com
• Phone: +4908152380
• Email: info@heine.com
• Phone: +4908152380
• Email: info@heine.com
• Phone: +4908152380
• Email: info@heine.com
• Phone: +4908152380
• Email: info@heine.com
• Phone: +4908152380
• Email: info@heine.com
• Phone: +4908152380
• Email: info@heine.com
• Phone: +4908152380
• Email: info@heine.com
• Phone: +4908152380
• Email: info@heine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053755202928 [Primary]

FDA Product Code

• KYT: Light, Examination, Medical, Battery Powered

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: 2025-05-08
• Device Publish Date: 2025-04-30

Devices Manufactured by Heine Optotechnik GmbH & Co. KG

• 04053755202928 - DELTAone: 2025-05-08
• 04053755202928 - DELTAone: 2025-05-08
• 04053755136988 - GAMMA 3.1: 2024-11-25
• 04053755136995 - GAMMA 3.2: 2024-11-25
• 04053755137015 - GAMMA 3.3: 2024-11-25
• 04053755137039 - GAMMA C.3: 2024-11-25
• 04053755179206 - BETA 400 LED F.O. OTOSCOPE: 2024-08-14
• 04053755201853 - visionPRO Mac 2: 2024-08-14
• 04053755202423 - MINI3000 LED OTOSCOPE: 2024-08-14 available also in blue