EdgeOne Fire™ MEOFMEDGP

GUDID 10818365020604

MIS EdgeOne™ Gutta Percha Points Medium

US ENDODONTICS, LLC

Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha Synthetic gutta-percha

• Primary Device ID: 10818365020604
• NIH Device Record Key: a90ef896-b889-4a9b-a58c-39a3ffb8f3a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EdgeOne Fire™
• Version Model Number: MEOFMEDGP
• Catalog Number: MEOFMEDGP
• Company DUNS: 061317427
• Company Name: US ENDODONTICS, LLC
• Device Count: 60
• 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818365020607 [Primary]
GS1	10818365020604 [Unit of Use]

FDA Product Code

• EKM: GUTTA-PERCHA

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-03
• Device Publish Date: 2023-06-25

On-Brand Devices [EdgeOne Fire™]

• 10818365020642: MIS EdgeOne™ Paper Points Large
• 10818365020635: MIS EdgeOne™ Paper Points Medium
• 10818365020628: MIS EdgeOne™ Paper Points Primary
• 10818365020611: MIS EdgeOne™ Paper Points Small
• 10818365020604: MIS EdgeOne™ Gutta Percha Points Medium
• 10818365020598: MIS EdgeOne™ Gutta Percha Points Primary
• 10818365020581: MIS EdgeOne™ Gutta Percha Points Small
• 10818365020475: MIS EdgeOne™ Gutta Percha Points Large