Acuity

GUDID 00850203008002

Rigid-gas-permeable contact lens - daily wear hexafocon A

ACUITY POLYMERS, INC.

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

• Primary Device ID: 00850203008002
• NIH Device Record Key: 263b6e89-52f6-4f95-a042-58dd6695cd0f
• Commercial Distribution Discontinuation: 2027-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acuity
• Version Model Number: 100
• Company DUNS: 045438768
• Company Name: ACUITY POLYMERS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Customer Support Contacts

• Phone: 585-458-8094
• Email: danielle.savino@acuitypolymers.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850203008002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162005

FDA Product Code

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

Sterilization

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

[00850203008002]

Liquid Chemical

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-27

On-Brand Devices [Acuity]

• 00850203008033: Rigid-gas-permeable contact lens - daily wear oprifocon A
• 00850203008026: Rigid-gas-permeable contact lens - daily wear enflufocon B
• 00850203008019: Rigid-gas-permeable contact lens - daily wear enflufocon A
• 00850203008002: Rigid-gas-permeable contact lens - daily wear hexafocon A