Optimum Extreme roflufocon E

GUDID 00865576000218

Rigid Gas Permeable Contact Lens

CONTAMAC HOLDINGS LIMITED

Rigid-gas-permeable corrective contact lens, daily-wear

• Primary Device ID: 00865576000218
• NIH Device Record Key: 13fe7ea2-2dfc-4e6a-947d-ab9ad151bf03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optimum Extreme
• Version Model Number: roflufocon E
• Catalog Number: roflufocon E
• Company DUNS: 216236887
• Company Name: CONTAMAC HOLDINGS LIMITED
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00865576000218 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033594
• Premarket Notification: K161100

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: 2020-07-30
• Device Publish Date: 2020-07-22

Devices Manufactured by CONTAMAC HOLDINGS LIMITED

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• 00865576000201 - Optimum Extra: 2020-07-30 Rigid Gas Permeable Contact Lens
• 00865576000218 - Optimum Extreme: 2020-07-30Rigid Gas Permeable Contact Lens
• 00865576000218 - Optimum Extreme: 2020-07-30 Rigid Gas Permeable Contact Lens
• 00865576000225 - Optimum Comfort: 2020-07-30 Rigid Gas Permeable Contact Lens
• 00865576000232 - Optimum Classic: 2020-07-30 Rigid Gas Permeable Contact Lens