Scleral Shell

GUDID G521V2627

Legrand Associates

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