EdgeEndo Sodium Hypochloite

GUDID 00818365020034

EdgeEndo sodium hypochlorite is a sodium hypochlorite solution in water with wetting agents to lower surface tension.

EDGE ENDO LLC

Dental tooth-cleaning solution Dental tooth-cleaning solution

• Primary Device ID: 00818365020034
• NIH Device Record Key: ea2b930b-22cc-4752-a006-acf5ee598f9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EdgeEndo Sodium Hypochloite
• Version Model Number: EENAOCL
• Company DUNS: 078474365
• Company Name: EDGE ENDO LLC
• Device Count: 1
• 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: false
• 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 Dimensions

• Total Volume: 480 Milliliter
• Total Volume: 480 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818365020034 [Primary]

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: 2018-10-05
• Device Publish Date: 2017-09-28

Devices Manufactured by EDGE ENDO LLC

• 00818365021031 - EdgeTemp™ Plus Hydraulic Temporary Restorative Material: 2020-09-07 EdgeTemp™ Plus is used for fabrication of temporary fillings for use until the permanent prosthetic is ready for installation.
• 10818365020932 - Edge™ EarLoop Procedure Masks”: 2020-05-06 Earloop Procedure Masks, ASTM Level 1, White, Box
• 10818365020949 - Edge™ EarLoop Procedure Masks: 2020-05-06 Earloop Procedure Masks, ASTM Level 1, Pink, Box
• 10818365020956 - Edge™ EarLoop Procedure Masks: 2020-05-06 Earloop Procedure Masks, ASTM Level 1, Blue, Box
• 10818365020963 - Edge™ EarLoop Procedure Masks: 2020-05-06 Earloop Procedure Masks, ASTM Level 2, White, Box
• 10818365020970 - Edge™ EarLoop Procedure Masks: 2020-05-06 Earloop Procedure Masks, ASTM Level 2, Pink, Box
• 10818365020987 - Edge™ EarLoop Procedure Masks: 2020-05-06 Earloop Procedure Masks, ASTM Level 2, Blue, Box
• 20818365020991 - Edge™ EarLoop Procedure Masks: 2020-05-06 Earloop Procedure Masks, ASTM Level 3, White, Box