3% NaOCL Sodium Hypochlorite

GUDID 10818207020397

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 ID10818207020397
NIH Device Record Key1d133976-d7cf-4430-9549-56c3f270d040
Commercial Distribution StatusIn Commercial Distribution
Brand Name3% NaOCL Sodium Hypochlorite
Version Model Number317018
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
GS110818207020397 [Primary]
GS110818207020397 [Primary]
GS110818207020397 [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 [3% NaOCL Sodium Hypochlorite]

10818207020427For the debridement and irrigation of root canals during and after instrumentation. 12ml kit.
10818207020410For the debridement and irrigation of root canals during and after instrumentation. 3ml kit.
10818207020403For the debridement and irrigation of root canals during and after instrumentation. 32 ounce bo
10818207020397For the debridement and irrigation of root canals during and after instrumentation. 16 ounce bot

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