Sweet Tooth Kristin Monthly

GUDID 08800071420552

Sweet Tooth Kristin Monthly/Gray Color/0.00/50EA

DK MEDIVISION Co.,Ltd.

Soft corrective contact lens, daily-wear
Primary Device ID08800071420552
NIH Device Record Key4869e018-5610-45b3-8732-e625b70e99fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameSweet Tooth Kristin Monthly
Version Model NumberSweet Tooth Kristin Monthly
Company DUNS688303758
Company NameDK MEDIVISION Co.,Ltd.
Device Count50
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS108800071415145 [Primary]
GS108800071420552 [Unit of Use]

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 Date2025-06-17
Device Publish Date2025-06-09

On-Brand Devices [Sweet Tooth Kristin Monthly]

08800071420804Sweet Tooth Kristin Monthly/Beige Color/0.00/50EA
08800071420552Sweet Tooth Kristin Monthly/Gray Color/0.00/50EA

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