Healthy Accents

GUDID 00725439991513

Healthy Accents Contact Lens Case 12-Pack

PROOPTICS LLC

Contact lens case

• Primary Device ID: 00725439991513
• NIH Device Record Key: 2d94ba9c-7e7a-4dae-9934-c739f7783d6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healthy Accents
• Version Model Number: 225-12HA
• 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	00725439991513 [Primary]

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: 2017-02-10

On-Brand Devices [Healthy Accents]

• 00725439991513: Healthy Accents Contact Lens Case 12-Pack
• 00725439991506: Healthy Accents Contact Lens Case 2-Pack