Chlor-XTRA

GUDID 10818207020496

Vista’s Chlor-XTRA™ is an enhanced 6% sodium hypochlorite solution designed for irrigation, debridement and cleansing of root canals during and after instrumentation. 3ml pre-filled syringes.

Vista Dental

Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution

• Primary Device ID: 10818207020496
• NIH Device Record Key: 49b7c17f-6029-406d-b016-4252798163d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chlor-XTRA
• Version Model Number: 503825
• Company DUNS: 036623932
• Company Name: Vista Dental
• Device Count: 10
• 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: 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	00818207020499 [Unit of Use]
GS1	10818207020496 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082470

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: 2
• Public Version Date: 2020-05-19
• Device Publish Date: 2018-08-06

On-Brand Devices [Chlor-XTRA]

• 10818207020502: Vista’s Chlor-XTRA™ is an enhanced 6% sodium hypochlorite solution designed for irrigation,
• 10818207020496: Vista’s Chlor-XTRA™ is an enhanced 6% sodium hypochlorite solution designed for irrigation,
• 10818207020489: Vista’s Chlor-XTRA™ is an enhanced 6% sodium hypochlorite solution designed for irrigation,
• 10818207020472: Vista’s Chlor-XTRA™ is an enhanced 6% sodium hypochlorite solution designed for irrigation,