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

GUDID 06975326564298

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-disposable
Primary Device ID06975326564298
NIH Device Record Keyeb0b3584-2b4f-4e77-9370-5d9e7aabd903
Commercial Distribution StatusIn Commercial Distribution
Brand Namecolor contact lens, BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Len
Version Model NumberBARBIE
Company DUNS543028405
Company NameShenzhen Dashicheng Optical Technology Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106975326564298 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPLLenses, Soft Contact, Daily Wear

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-19
Device Publish Date2024-03-11

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

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

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