Scleral Shell E661089

GUDID B863E661089V2627

TEXAS EYE PROSTHETICS LLC

Scleral shell

• Primary Device ID: B863E661089V2627
• NIH Device Record Key: b1e08264-8e1d-4e06-b86e-316ce0717db3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scleral Shell
• Version Model Number: V2627
• Catalog Number: E661089
• Company DUNS: 016863467
• Company Name: TEXAS EYE PROSTHETICS LLC
• 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

Customer Support Contacts

• Phone: 7135241001
• Email: texaseyepros@gmail.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B863E661089V2627 [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: 2020-04-22
• Device Publish Date: 2020-04-14

Devices Manufactured by TEXAS EYE PROSTHETICS LLC

• B863E661087V2623 - Artificial Eye, Plastic, Custom: 2020-04-22
• B863E661089V2627 - Scleral Shell: 2020-04-22
• B863E661089V2627 - Scleral Shell: 2020-04-22
• B863E661090V2628 - Ophthalmic Conformer: 2020-04-22