Dallas Eye Prosthetics

GUDID 00860015162816

Scleral Shell

Dallas Eye Prosthetics

Eyeball prosthesis, custom-made

• Primary Device ID: 00860015162816
• NIH Device Record Key: 21e23d0d-0b08-482d-872a-520f420f66d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dallas Eye Prosthetics
• Version Model Number: 1
• Company DUNS: 148169683
• Company Name: Dallas Eye Prosthetics
• 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: true
• Serial Number: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860015162816 [Primary]

FDA Product Code

• HQT: Shell, Scleral

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: 2025-12-31
• Device Publish Date: 2025-12-23

On-Brand Devices [Dallas Eye Prosthetics]

• 00860015162823: Ophthalmic Conformer
• 00860015162816: Scleral Shell
• 00860015162809: Artificial Eye