CHX Plus

GUDID 10818207020373

Contains 2% Chlorhexidine Gluconate plus powerful wetting agents and proprietary surface modifiers to improve the depth of penetration and kill bacteria. Unit dose includes (30) .6mL individually packaged prefilled syringes & (30) 27ga side-vent irrigating tips.

Vista Dental

Root canal cleaning solution
Primary Device ID10818207020373
NIH Device Record Key7fb7d023-5fbd-4882-964b-016583b32b04
Commercial Distribution StatusIn Commercial Distribution
Brand NameCHX Plus
Version Model Number503925
Company DUNS036623932
Company NameVista Dental
Device Count30
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS100818207020376 [Unit of Use]
GS110818207020373 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KJJCleanser, Root Canal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-05-06
Device Publish Date2018-07-31

On-Brand Devices [CHX Plus]

10818207020373Contains 2% Chlorhexidine Gluconate plus powerful wetting agents and proprietary surface modifie
10818207020366Contains 2% Chlorhexidine Gluconate plus powerful wetting agents and proprietary surface modifie
10818207020359Contains 2% Chlorhexidine Gluconate plus powerful wetting agents and proprietary surface modifie
10818207020342Contains 2% Chlorhexidine Gluconate plus powerful wetting agents and proprietary surface modifie
10818207020335Contains 2% Chlorhexidine Gluconate plus powerful wetting agents and proprietary surface modifie
10818207020328Contains 2% Chlorhexidine Gluconate plus powerful wetting agents and proprietary surface modifie
10818207020311Contains 2% Chlorhexidine Gluconate plus powerful wetting agents and proprietary surface modifie

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