AccessGUDID - DEVICE: ArtMost SoftOK Daily Wear Soft Contact Lens (04713025867447)

GUDID

Device Identifier (DI) Information

Brand Name: ArtMost SoftOK Daily Wear Soft Contact Lens
Version or Model: STC/-11.00D
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SEINOH OPTICAL CO., LTD.

Primary DI Number: 04713025867447
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 658826479 *Terms of Use

Device Description: 6 sterile daily wear soft contact lenses, 45% Ocufilcon D, 55% water.

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141280	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
Outer Diameter: 14.4 Millimeter

Device Record Status

Public Device Record Key: 8cdd4c9a-aa5c-4e2f-bac5-5c30e3bf37ca
Public Version Date: December 04, 2023
Public Version Number: 4
DI Record Publish Date: May 08, 2017