EdgeSurgicalTip™ #1

GUDID 00818365020096

Universal diamond-coated apical surgery tip for the retro-preparation of canals of anterior

EDGE ENDO LLC

Ultrasonic dental scaling/debridement system handpiece tip, endodontic

• Primary Device ID: 00818365020096
• NIH Device Record Key: e7bdd804-ff29-43be-8ce7-ac7faae6b2ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EdgeSurgicalTip™ #1
• Version Model Number: AS3D1
• 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: false
• 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	00818365020096 [Primary]

FDA Product Code

• ELC: Scaler, Ultrasonic

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: 2019-02-21
• Device Publish Date: 2018-06-10

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