FDA.reportPublic FDA data

Lugols

Primary DI
00348783001242
Brand
Lugols
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
9045056
Device description
Lugol’s Solution, 8ml bottles with applicators- 12 pack
Published
2023-05-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IAMSolution, Lugol'S

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IAMSolution, Lugol'SPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00348783001242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00348783001242003487830012423487830012420348783001242

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopy mucosal lesion stainA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
014789663
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00348783010640Premier Jackson Original Tracheostomy Tube10343002026-06-09
00348783010657Premier Jackson Original Tracheostomy Tube10343102026-06-09
00348783010664Premier Jackson Original Tracheostomy Tube10343112026-06-09
00348783010671Premier Jackson Original Tracheostomy Tube10343122026-06-09
00348783010695Premier Jackson Original Tracheostomy Tube10343142026-06-09
00348783010701Premier Jackson Original Tracheostomy Tube10343152026-06-09
00348783010718Premier Jackson Original Tracheostomy Tube10343162026-06-09
00348783010725Premier Jackson Original Tracheostomy Tube10343172026-06-09
00348783010732Premier Jackson Original Tracheostomy Tube10343182026-06-09
00348783010749Premier Jackson Original Tracheostomy Tube10343192026-06-09
00348783010756Premier Jackson Original Tracheostomy Tube10343202026-06-09
00348783010770Premier Jackson Improved Tracheostomy Tube10346102026-06-09
00348783010787Premier Jackson Improved Tracheostomy Tube10346112026-06-09
00348783010794Premier Jackson Improved Tracheostomy Tube10346122026-06-09
00348783010800Premier Jackson Improved Tracheostomy Tube10346132026-06-09
00348783010817Premier Jackson Improved Tracheostomy Tube10346142026-06-09
00348783010824Premier Jackson Improved Tracheostomy Tube10346152026-06-09
00348783010831Premier Jackson Improved Tracheostomy Tube10346162026-06-09
00348783010848Premier Jackson Improved Tracheostomy Tube10346172026-06-09
00348783010855Premier Jackson Improved Tracheostomy Tube10346182026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783015577Gynex LugolsPREMIER DENTAL PRODUCTS COMPANYIAM2026-02-03
10348783015574Gynex LugolsPREMIER DENTAL PRODUCTS COMPANYIAM2026-02-03