Shell, Scleral

GUDID B796V2627

MIDWEST EYE LABORATORIES, INC.

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: B796V2627
• NIH Device Record Key: 033e86fc-c87f-458e-a9d2-ffad44343509
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shell, Scleral
• Version Model Number: V2627
• Company DUNS: 157524570
• Company Name: MIDWEST EYE LABORATORIES, INC.
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B796V2627 [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: 2024-04-04
• Device Publish Date: 2024-03-27

Devices Manufactured by MIDWEST EYE LABORATORIES, INC.

• B796V2628 - Ophthalmic Conformer: 2024-04-05
• B796V2623 - Eye, Artificial, Non-Custom: 2024-04-04
• B796V2627 - Shell, Scleral: 2024-04-04
• B796V2627 - Shell, Scleral: 2024-04-04