CHX Plus

GUDID 10818207020359

Contains 2% Chlorhexidine Gluconate plus powerful wetting agents and proprietary surface modifiers to improve the depth of penetration and kills bacteria. 30ml Bulk Syringe Kit Includes: (1) 30mL prefilled bulk syringe, (20) 1.2cc syringes, (20) 27ga side-vent irrigating tips & (1) docking port.

Vista Dental

Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution

• Primary Device ID: 10818207020359
• NIH Device Record Key: 819fd90d-7f4f-49cc-a4b7-c647971955d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHX Plus
• Version Model Number: 503400
• Company DUNS: 036623932
• Company Name: Vista Dental
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10818207020359 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112250

FDA Product Code

• KJJ: Cleanser, Root Canal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-05-06
• Device Publish Date: 2018-06-19

On-Brand Devices [CHX Plus]

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