EdgeEndo Chlohexidine

Basic Information

• Brand Name: EdgeEndo Chlohexidine
• Primary DI: 00818365020041
• Version / Model: EECHX
• Company Name: EDGE ENDO LLC
• Labeler DUNS: 078474365
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-28
• Public Version: 3
• Public Version Date: 2018-10-05
• Public Version Status: Update
• Public Device Record Key: cc619787-4619-4d3d-94a5-d6a3b73e1342

Device Description

EdgeEndo Chlohexidine is a 2% Chlorhexidine Gluconate solution in water with surfactant to lower surface tension. The solution is a root canal cleanser for use in endotontic procedures.

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: No
• 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
34524	Dental tooth-cleaning solution	A liquid or gel substance intended to be applied by a dental professional to clean tooth surfaces/cavities, often prior to or following a dental procedure (e.g., restoration, implantation). It typically contains appropriate cleaning agents and may be formulated to prevent plaque accumulation and gingivitis. It is often applied with a syringe, which may be included. 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	00818365020041	GS1

Device Sizes

Type	Value	Unit	Text
Total Volume	480	Milliliter