6% NaOCL Sodium Hypochlorite

Basic Information

• Brand Name: 6% NaOCL Sodium Hypochlorite
• Primary DI: 10818207020441
• Version / Model: 281403
• Company Name: Vista Dental
• Labeler DUNS: 036623932
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2018-08-06
• Public Version: 5
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 2f0eeedf-ae1f-4ddf-8897-7d569f7a6a6b
• Distribution End Date: 2021-01-29

Device Description

For debridement and irrigation of root canals during or after instrumentation. 32 ounce bottle.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KJJ	Cleanser, Root Canal	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
59523	Antimicrobial wound irrigation solution	A solution that includes an antimicrobial agent (e.g., sodium hypochlorite) intended to be used to irrigate and clean acute or chronic wounds, including first or second degree burns, to aid in autolytic debridement and to moisten a wound dressing(s), and to support natural healing. It is intended to be used in the home or healthcare facility. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10818207020441	GS1
Unit of Use	00818207020444	GS1