Optimum HR 1.53 hirafocon B

GUDID 00865576000256

Rigid Gas Permeable Contact Lens

CONTAMAC HOLDINGS LIMITED

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

• Primary Device ID: 00865576000256
• NIH Device Record Key: 7f99119b-4cec-4d8d-acfb-086895cf1fcd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optimum HR 1.53
• Version Model Number: hirafocon B
• Catalog Number: hirafocon B
• 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	00865576000256 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081178

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: 2020-08-05
• Device Publish Date: 2020-07-28

Devices Manufactured by CONTAMAC HOLDINGS LIMITED

• 00865576000249 - Optimum HR 1.51: 2020-08-05 Rigid Gas Permeable Contact Lens
• 00865576000256 - Optimum HR 1.53: 2020-08-05Rigid Gas Permeable Contact Lens
• 00865576000256 - Optimum HR 1.53: 2020-08-05 Rigid Gas Permeable Contact Lens
• 00865576000270 - Hybird FS: 2020-08-05 Rigid Gas Permeable Contact Lens
• 00865576000294 - Optimum Infinite: 2020-08-05 Rigid Gas Permeable Contact Lens
• 00865576000201 - Optimum Extra: 2020-07-30 Rigid 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