Lugols

GUDID 00348783001242

Lugol’s Solution, 8ml bottles with applicators- 12 pack

PREMIER DENTAL PRODUCTS COMPANY

Endoscopy mucosal lesion stain
Primary Device ID00348783001242
NIH Device Record Key72757169-f252-46a4-ac1a-3a125a68611e
Commercial Distribution StatusIn Commercial Distribution
Brand NameLugols
Version Model Number9045056
Company DUNS014789663
Company NamePREMIER DENTAL PRODUCTS COMPANY
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100348783001242 [Primary]

FDA Product Code

IAMSolution, Lugol'S

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-17
Device Publish Date2023-05-09

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