Chlor-XTRA

GUDID 10818207020502

Vista’s Chlor-XTRA™ is an enhanced 6% sodium hypochlorite solution designed for irrigation, debridement and cleansing of root canals during and after instrumentation. 12ml pre-filled syringes.

Vista Dental

Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile
Primary Device ID10818207020502
NIH Device Record Keybc63ed82-fbc0-430d-a382-d085ac9d79d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameChlor-XTRA
Version Model Number503850
Company DUNS036623932
Company NameVista Dental
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
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 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
GS100818207020505 [Unit of Use]
GS100818207020505 [Unit of Use]
GS110818207020502 [Primary]
GS110818207020502 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KJJCleanser, Root Canal
KJJCleanser, Root Canal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-05-19
Device Publish Date2018-08-06

On-Brand Devices [Chlor-XTRA]

10818207020502Vista’s Chlor-XTRA™ is an enhanced 6% sodium hypochlorite solution designed for irrigation,
10818207020496Vista’s Chlor-XTRA™ is an enhanced 6% sodium hypochlorite solution designed for irrigation,
10818207020489Vista’s Chlor-XTRA™ is an enhanced 6% sodium hypochlorite solution designed for irrigation,
10818207020472Vista’s Chlor-XTRA™ is an enhanced 6% sodium hypochlorite solution designed for irrigation,

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