GUDID 00697077002930

Amico Diagnostic Incorporated

Direct ophthalmoscope Direct ophthalmoscope Direct ophthalmoscope Direct ophthalmoscope Direct ophthalmoscope Direct ophthalmoscope Direct ophthalmoscope Direct ophthalmoscope Direct ophthalmoscope Direct ophthalmoscope Direct ophthalmoscope Direct ophthalmoscope Direct ophthalmoscope Direct ophthalmoscope Direct ophthalmoscope Direct ophthalmoscope

• Primary Device ID: 00697077002930
• NIH Device Record Key: 67bb2252-0365-4b10-848b-d77fdd0d33df
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: DS-EDM-CLFL-XXX
• Company DUNS: 203163290
• Company Name: Amico Diagnostic Incorporated
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00697077002930 [Primary]

FDA Product Code

• HLI: Ophthalmoscope, Ac-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: 2022-02-10
• Device Publish Date: 2022-02-02

Devices Manufactured by Amico Diagnostic Incorporated

• 00697077003029 - NA: 2024-05-10
• 00697077002237 - NA: 2023-08-04
• 00697077002985 - NA: 2023-08-04
• 00697077002992 - NA: 2023-08-04
• 00697077003005 - NA: 2023-08-04
• 00697077003012 - NA: 2023-08-04
• 00697077002978 - NA: 2023-07-13
• 00697077002961 - NA: 2023-04-26