AccessGUDID - DEVICE: Unicoeye;BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens (06931219402290)

GUDID

Device Identifier (DI) Information

Brand Name: Unicoeye;BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens
Version or Model: BARBIE
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shenzhen Dashicheng Optical Technology Co., Ltd.

Primary DI Number: 06931219402290
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 543028405 *Terms of Use

Device Description: 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 0.50 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. 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47842	Soft corrective contact lens, daily-wear	A soft ophthalmic lens intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct refractive vision conditions that occur naturally (e.g., myopia, hyperopia, astigmatism, presbyopia) or post surgery; it is designed to be removed prior to sleeping each night. The device may be coloured/tinted for easier handling or to change the appearance of the eye for cosmetic purposes; it may include an ultraviolet blocker. The device is made of various synthetic polymer materials, the main polymer molecules being hydrophilic (e.g., hydrogel); it permits diffusion of oxygen (O2) to the ocular surface. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LPL	Lenses, Soft Contact, Daily Wear
MVN	Lens, Contact, (Disposable)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K220143	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f19fc77d-7e14-4b82-9b77-3d15f1f1354a
Public Version Date: March 26, 2025
Public Version Number: 1
DI Record Publish Date: March 18, 2025