AccessGUDID - DEVICE: Sophisticated Kristin Monthly (08800071415312)

GUDID

Device Identifier (DI) Information

Brand Name: Sophisticated Kristin Monthly
Version or Model: Sophisticated Kristin Monthly
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DK MEDIVISION Co.,Ltd.

Primary DI Number: 08800071415312
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 688303758 *Terms of Use

Device Description: Sophisticated Kristin Monthly/Olive Color/-3.75/100EA

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):	No
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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K220045	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: 462d421a-cbb2-4c30-a192-73e77df923a6
Public Version Date: June 17, 2025
Public Version Number: 1
DI Record Publish Date: June 09, 2025