Hello, eyes

GUDID 08800024300672

Our BIO Plug is a medical device designed for the treatment of dry eye syndrome. It is inserted into the lacrimal punctum gland to minimize the drainage of tears through the tear duct, thereby alleviating symptoms of dry eye.

Bio Optics Co., Ltd

Lacrimal punctum plug

• Primary Device ID: 08800024300672
• NIH Device Record Key: f4f97e1a-8f72-424a-9228-e115accf5e5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hello, eyes
• Version Model Number: BIO Plug 0.3
• Company DUNS: 690427205
• Company Name: Bio Optics Co., Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Manufacturing Date: true
• Expiration Date: true
• 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
GS1	08800024300672 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241229

FDA Product Code

• LZU: Plug, Punctum

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-07
• Device Publish Date: 2024-07-30

On-Brand Devices [Hello, eyes]

• 08800024300672: Our BIO Plug is a medical device designed for the treatment of dry eye syndrome. It is inserted
• 08800024300016: Our BIO Plug is a medical device designed for the treatment of dry eye syndrome. It is inserted
• 08800024300009: Our BIO Plug is a medical device designed for the treatment of dry eye syndrome. It is inserted