Home GUDID 10348783015574 Gynex Lugols
Primary DI 10348783015574
Brand Gynex Lugols
Company PREMIER DENTAL PRODUCTS COMPANY
Model 9045066
Device description Lugol's Strong Iodine Solution, Non-Sterile, Single-Patient-Use, 12 single application - 8mL vials, 12 rayon tipped applicators
Published 2026-02-03
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name IAM Solution, Lugol'S
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class IAM Solution, Lugol'S Pathology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10348783015574 Package GS1 20 In Commercial Distribution 00348783015577 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10348783015574 10348783015574 00348783015577 00348783015577 348783015577 0348783015577
GMDN Terms# Term, Definition table Term Definition Endoscopy mucosal lesion stain A solution containing a dye (e.g., iodine, indigo carmine) intended to be used during endoscopic procedures (e.g., gastroscopy, colposcopy) to stain epithelial surfaces to help screen for mucosal lesions [e.g., oesophageal squamous dysplasia, gastrointestinal polyps, adenomas, cervical carcinoma]. It is typically applied onto the epithelium whereby lesions are observed by visualization of stained or unstained tissue. After application, this device cannot be reused.
Regulatory Flags# DUNS number 014789663 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00348783015577 Gynex Lugols PREMIER DENTAL PRODUCTS COMPANY IAM 2026-02-03 00348783001242 Lugols PREMIER DENTAL PRODUCTS COMPANY IAM 2023-05-09