Scleral Shell

GUDID G521V2627

Legrand Associates

Scleral shell Scleral shell Scleral shell Scleral shell Scleral shell Scleral shell Scleral shell Scleral shell Scleral shell Scleral shell Scleral shell Scleral shell Scleral shell Scleral shell Scleral shell Scleral shell Scleral shell Scleral shell

• Primary Device ID: G521V2627
• NIH Device Record Key: 493f0bd2-684b-46bb-ba4e-eef035c3ed42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scleral Shell
• Version Model Number: V2627
• Company DUNS: 002306975
• Company Name: Legrand Associates
• 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: true
• Lot Batch: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G521V2627 [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: 2023-10-26
• Device Publish Date: 2023-10-18

Devices Manufactured by Legrand Associates

• G521V2623 - Artificial Eye, Plastic, Custom: 2023-10-26
• G521V2627 - Scleral Shell: 2023-10-26
• G521V2627 - Scleral Shell: 2023-10-26
• G521V2628 - Ophthalmic Conformer: 2023-10-26