Harmon Face Values

GUDID 30075063122502

PROOPTICS LLC

Contact lens case

• Primary Device ID: 30075063122502
• NIH Device Record Key: 23d987a2-c7d2-4e7a-985d-ee3173a907bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harmon Face Values
• Version Model Number: 225FV
• Company DUNS: 002977189
• Company Name: PROOPTICS LLC
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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
GS1	00075063122501 [Primary]
GS1	30075063122502 [Package]; Contains: 00075063122501; Package: Carton [144 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K875197

FDA Product Code

• LRX: Case, Contact Lens

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-09

On-Brand Devices [Harmon Face Values]

• 30075063122502: 225FV
• 00075063112502: Harmon Face Values Flip-Top Contact Lens Case