Monolith Tatar 'n' Stain Remover

GUDID 04064896000274

PRISMAN INC.

Denture cleanser
Primary Device ID04064896000274
NIH Device Record Keya374b44c-4bb0-4129-acfa-39dd61b9f899
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonolith Tatar 'n' Stain Remover
Version Model NumberM351
Company DUNS117569946
Company NamePRISMAN INC.
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104064896000274 [Primary]

FDA Product Code

FLGCleaner, Ultrasonic, Medical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-18
Device Publish Date2021-10-10