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
00348783008500Premier Excavators10034402026-06-08
00348783008517Premier Excavators10034412026-06-08
00348783008524Premier Excavators10034422026-06-08
00348783008531Premier Excavators10034432026-06-08
00348783008548Premier Excavators10034462026-06-08
00348783008555Premier Excavators10034472026-06-08
00348783008562Premier Excavators10034482026-06-08
00348783008579Premier Excavators10034492026-06-08
00348783008609Premier Excavators10034532026-06-08
00348783008616Premier Excavators10034542026-06-08
00348783008623Premier Excavators10034622026-06-08
00348783008647Premier Excavators10034642026-06-08
00348783008661Premier Excavators10038412026-06-08
00348783008685Premier Excavators10038502026-06-08
00348783008692Premier Excavators10038832026-06-08
00348783008708Premier Excavators10038842026-06-08
00348783008715Premier Excavators10038852026-06-08
00348783011142Premier Decann Stopper10378342026-06-08
00348783011159Premier Decann Stopper10378352026-06-08
00348783011166Premier Decann Stopper10378362026-06-08

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