color contact lens, BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Len

GUDID 06975326564304

BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia. The lens may be worn by persons who exhibit refractive astigmatism of diopters or less where the astigmatism does not interfere with visual acuity. The lens is available tinted and used to enhance or alter the apparent color of the eye. Daily wear replacement schedules may vary from patient to patient and should be decided by eyecare practitioners in consultation with their patients. Frequent/Planned Replacement Wear: Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system. Disposable Wear: Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When prescribed for Daily Disposable Wear, the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.

Shenzhen Dashicheng Optical Technology Co., Ltd.

Soft corrective contact lens, daily-wear

• Primary Device ID: 06975326564304
• NIH Device Record Key: 23f313cc-2764-4ac9-97ba-64e3d0a16fa1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: color contact lens, BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Len
• Version Model Number: BARBIE
• Company DUNS: 543028405
• Company Name: Shenzhen Dashicheng Optical Technology Co., Ltd.
• 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: true
• Expiration Date: true
• 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	06975326564304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220143

FDA Product Code

• LPL: Lenses, Soft Contact, Daily Wear

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-19
• Device Publish Date: 2024-03-11

On-Brand Devices [color contact lens, BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Len]

• 06975326564304: BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens are indicated for the correction o
• 06975326564298: BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens are indicated for the correction o