Eye, Artificial, Non-Custom

GUDID B796V2623

MIDWEST EYE LABORATORIES, INC.

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• Primary Device ID: B796V2623
• NIH Device Record Key: 2469b1ec-251b-4212-b278-7087d4555db6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eye, Artificial, Non-Custom
• Version Model Number: V2623
• 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	B796V2623 [Primary]

FDA Product Code

• HQH: Eye, Artificial, Non-Custom

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
• B796V2623 - Eye, Artificial, Non-Custom: 2024-04-04
• B796V2627 - Shell, Scleral: 2024-04-04