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 ID: 10348783015574
• NIH Device Record Key: 0629cd71-9a5b-4796-ae6e-fd7e622ff014
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gynex Lugols
• Version Model Number: 9045066
• Company DUNS: 014789663
• Company Name: PREMIER DENTAL PRODUCTS COMPANY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00348783015577 [Primary]
GS1	10348783015574 [Package]; Contains: 00348783015577; Package: case [20 Units]; In Commercial Distribution

FDA Product Code

• IAM: Solution, Lugol'S

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-11
• Device Publish Date: 2026-02-03

Devices Manufactured by PREMIER DENTAL PRODUCTS COMPANY

• 10348783015574 - Gynex Lugols: 2026-02-11Lugol's Strong Iodine Solution, Non-Sterile, Single-Patient-Use, 12 single application - 8mL vials, 12 rayon tipped applicators
• 10348783015574 - Gynex Lugols: 2026-02-11 Lugol's Strong Iodine Solution, Non-Sterile, Single-Patient-Use, 12 single application - 8mL vials, 12 rayon tipped applicators
• 00348783015348 - MultiMatch Flow Chameleon AntiMicrobial Composite: 2026-02-10 MultiMatch Flow Standard Pack
• 00348783015355 - MultiMatch Flow Chameleon AntiMicrobial Composite: 2026-02-10 MultiMatch Flow Sample
• 00348783015362 - MultiMatch Flow Chameleon AntiMicrobial Composite: 2026-02-10 MultiMatch Flow Value Pack
• 00348783015379 - MultiMatch Flow Chameleon AntiMicrobial Composite: 2026-02-10 MultiMatch Flow Unit Dose Pack
• 00348783015386 - MultiMatch Flow Chameleon AntiMicrobial Composite: 2026-02-10 MultiMatch Flow Unit Dose Sample Pack
• 00348783012989 - Enamel Pro® Prophy Paste: 2025-07-24 Enamel Pro® Prophy Paste Grape-Medium
• 00348783005134 - RC-Prep: 2025-07-17 RC PREP PLASTIC 9G SYR TIP REFILL (50)