6% NaOCL Sodium Hypochlorite

GUDID 10818207020434

For the debridement and irrigation of root canals during and after instrumentation. 16 ounce bottle.

Vista Dental

Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile
Primary Device ID10818207020434
NIH Device Record Key02ebd491-af3b-4ad1-8e53-51a91a6661fe
Commercial Distribution StatusIn Commercial Distribution
Brand Name6% NaOCL Sodium Hypochlorite
Version Model Number317008
Company DUNS036623932
Company NameVista Dental
Device Count1
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
GS110818207020434 [Primary]
GS110818207020434 [Primary]
GS110818207020434 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KJJCleanser, Root Canal
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 [6% NaOCL Sodium Hypochlorite]

10818207020465For debridement and irrigation of root canals during and after instrumentation. 12ml kit.
10818207020458For debridement and irrigation of root canals during and after instrumentation. 3ml kit.
10818207020441For debridement and irrigation of root canals during or after instrumentation. 32 ounce bottle.
10818207020434For the debridement and irrigation of root canals during and after instrumentation. 16 ounce bo

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