Ophthalmic Conformer

GUDID B796V2628

MIDWEST EYE LABORATORIES, INC.

Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer

• Primary Device ID: B796V2628
• NIH Device Record Key: 21c204f8-babf-4163-9d8c-765efba5512e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ophthalmic Conformer
• Version Model Number: V2628
• 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	B796V2628 [Primary]

FDA Product Code

• HQN: Conformer, Ophthalmic

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: 2024-04-05
• Device Publish Date: 2024-03-28

Devices Manufactured by MIDWEST EYE LABORATORIES, INC.

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