Custom Stable

GUDID 00860011844112

Rigid Gas Permeable Scleral Contact Lens for Daily Wear

Valley Contax, Inc.

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• Primary Device ID: 00860011844112
• NIH Device Record Key: dbd5b153-4a1a-470c-90f5-96578662688c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Custom Stable
• Version Model Number: Optimum Exra (roflufocon D) Clear
• Company DUNS: 013969530
• Company Name: Valley Contax, Inc.
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011844112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213880

FDA Product Code

• HQD: Lens, Contact (Other Material) - Daily

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: 2024-04-16
• Device Publish Date: 2024-04-08

On-Brand Devices [Custom Stable]

• 00860011844112: Rigid Gas Permeable Scleral Contact Lens for Daily Wear
• 00860011844105: Rigid Gas Permeable Scleral Contact Lens for Daily Wear