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 ID: 10818207020373
• NIH Device Record Key: 7fb7d023-5fbd-4882-964b-016583b32b04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHX Plus
• Version Model Number: 503925
• Company DUNS: 036623932
• Company Name: Vista Dental
• Device Count: 30
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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	00818207020376 [Unit of Use]
GS1	10818207020373 [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: 2018-07-31

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