Gynex Lugols

Basic Information

• Brand Name: Gynex Lugols
• Primary DI: 00348783015577
• Version / Model: 9045066
• Company Name: PREMIER DENTAL PRODUCTS COMPANY
• Labeler DUNS: 014789663
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-03
• Public Version: 1
• Public Version Date: 2026-02-11
• Public Version Status: New
• Public Device Record Key: 0629cd71-9a5b-4796-ae6e-fd7e622ff014

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IAM	Solution, Lugol'S	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64166	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10348783015574	GS1	case	20	In Commercial Distribution
Primary	00348783015577	GS1