Gynex Lugols

GUDID 10348783015574

Lugol's Strong Iodine Solution, Non-Sterile, Single-Patient-Use, 12 single application - 8mL vials, 12 rayon tipped applicators

PREMIER DENTAL PRODUCTS COMPANY

Endoscopy mucosal lesion stain
Primary Device ID10348783015574
NIH Device Record Key0629cd71-9a5b-4796-ae6e-fd7e622ff014
Commercial Distribution StatusIn Commercial Distribution
Brand NameGynex Lugols
Version Model Number9045066
Company DUNS014789663
Company NamePREMIER DENTAL PRODUCTS COMPANY
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100348783015577 [Primary]
GS110348783015574 [Package]
Contains: 00348783015577
Package: case [20 Units]
In Commercial Distribution

FDA Product Code

IAMSolution, Lugol'S

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-11
Device Publish Date2026-02-03

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