CHX

GUDID 10818207020304

2% Chlorhexidine Gluconate - use prior to restorative preparations of crowns and composites. Restorative kit includes (4) 1.2ml prefilled syringes & 40 Sol-u-Flo tips.

Vista Dental

Root canal cleaning solution

• Primary Device ID: 10818207020304
• NIH Device Record Key: 950a46e6-c59f-43f3-81b3-6c9f3d7ebe05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHX
• Version Model Number: 502450
• Company DUNS: 036623932
• Company Name: Vista Dental
• Device Count: 4
• 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	00818207020307 [Unit of Use]
GS1	10818207020304 [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]

• 10818207020304: 2% Chlorhexidine Gluconate - use prior to restorative preparations of crowns and composites. Res
• 10818207020298: 2% Chlorhexidine Gluconate - use prior to restorative preparations of crowns and composites. 30m
• 10818207020281: 2% Chlorhexidine Gluconate - use prior to restorative preparations of crowns and composites. 16