EdgeSequel Utopia ES300631SE

GUDID 10810047645556

Sterile Endodontic Rotary File

US ENDODONTICS, LLC

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• Primary Device ID: 10810047645556
• NIH Device Record Key: 5ad775af-34eb-4987-b922-9ec16e741080
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EdgeSequel Utopia
• Version Model Number: ES300631SE
• Catalog Number: ES300631SE
• Company DUNS: 061317427
• Company Name: US ENDODONTICS, LLC
• Device Count: 6
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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

Customer Support Contacts

• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810047645559 [Primary]
GS1	10810047645556 [Unit of Use]

FDA Product Code

• EKS: FILE, PULP CANAL, ENDODONTIC

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-07
• Device Publish Date: 2023-07-28

On-Brand Devices [EdgeSequel Utopia]

• 10810047645648: Sterile Endodontic Rotary File
• 10810047645631: Sterile Endodontic Rotary File
• 10810047645624: Sterile Endodontic Rotary File
• 10810047645617: Sterile Endodontic Rotary File
• 10810047645600: Sterile Endodontic Rotary File
• 10810047645594: Sterile Endodontic Rotary File
• 10810047645587: Sterile Endodontic Rotary File
• 10810047645570: Sterile Endodontic Rotary File
• 10810047645563: Sterile Endodontic Rotary File
• 10810047645556: Sterile Endodontic Rotary File
• 10810047645549: Sterile Endodontic Rotary File
• 10810047645532: Sterile Endodontic Rotary File
• 10810047645525: Sterile Endodontic Rotary File
• 10810047645518: Sterile Endodontic Rotary File
• 10810047645501: Sterile Endodontic Rotary File
• 10810047645495: Sterile Endodontic Rotary File
• 10810047645488: Sterile Endodontic Rotary File
• 10810047645471: Sterile Endodontic Rotary File
• 10810047645464: Sterile Endodontic Rotary File
• 10810047645457: Sterile Endodontic Rotary File
• 10810047645440: Sterile Endodontic Rotary File
• 10810047645433: Sterile Endodontic Rotary File
• 10810047645426: Sterile Endodontic Rotary File
• 10810047645419: Sterile Endodontic Rotary File
• 10810047645402: Sterile Endodontic Rotary File
• 10810047645396: Sterile Endodontic Rotary File
• 10810047645389: Sterile Endodontic Rotary File
• 10810047645372: Sterile Endodontic Rotary File
• 10810047645365: Sterile Endodontic Rotary File
• 10810047645358: Sterile Endodontic Rotary File