EZ-TRI-3600

GUDID 00850038195564

3.5V Bivalve Nasal Speculum EZ-TRI-3600

U.S. OPHTHALMIC, L.L.C.

ENT transilluminator

• Primary Device ID: 00850038195564
• NIH Device Record Key: a386c27f-4c8b-4d3d-8c44-5feccec0a6e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZ-TRI-3600
• Version Model Number: EZ-TRI-3600
• Company DUNS: 166760392
• Company Name: U.S. OPHTHALMIC, L.L.C.
• 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: true
• 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	00850038195564 [Primary]

FDA Product Code

• HJN: Transilluminator, 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: 2025-02-27
• Device Publish Date: 2025-02-19

Devices Manufactured by U.S. OPHTHALMIC, L.L.C.

• 00850038195564 - EZ-TRI-3600: 2025-02-273.5V Bivalve Nasal Speculum EZ-TRI-3600
• 00850038195564 - EZ-TRI-3600: 2025-02-27 3.5V Bivalve Nasal Speculum EZ-TRI-3600
• 00850038195557 - LuxVsion: 2024-04-16 Luxvision Digital Refractor LDR-7800
• 00851158007805 - Eli Ezer: 2024-04-16 Digital Refractor Ezer EDR-H
• 00851158007836 - Eli Ezer: 2024-04-16 Digital Refractor Ezer EDR-9000 A
• 00850038195335 - Eli Ezer: 2024-04-11 EZ-OPH-3600 ophthalmoscope HALOGEN Lamp
• 00850038195342 - Eli Ezer: 2024-04-11 EZ-OPH-3600 ophthalmoscope LED Lamp
• 00851158007621 - Eli Ezer: 2024-02-02 ESL-Emerald-1
• 00851158007638 - Eli Ezer: 2024-02-02 ESL-Emerald-8