Shell, Scleral

GUDID B796V2627

MIDWEST EYE LABORATORIES, INC.

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