EdgeOne™ EOPPRIGP

GUDID 10818365029454

Slim Fit EdgeOne™ Gutta Percha Points Primary

US ENDODONTICS, LLC

Synthetic gutta-percha

• Primary Device ID: 10818365029454
• NIH Device Record Key: de468e93-45d0-4498-9fdb-1a96bc11b1b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EdgeOne™
• Version Model Number: EOPPRIGP
• Catalog Number: EOPPRIGP
• 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	00818365029457 [Primary]
GS1	10818365029454 [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™]

• 20818365021691: Classic Fit EdgeOne™ Paper Points Large
• 20818365021684: Classic Fit EdgeOne™ Paper Points Medium
• 20818365021677: Classic Fit EdgeOne™ Paper Points Primary
• 20818365021660: Classic Fit EdgeOne™ Paper Points Small
• 20818365021653: Classic Fit EdgeOne™ Paper Points Verifile™
• 20818365021646: Classic Fit EdgeOne™ Gutta Percha Points Large
• 20818365021639: Classic Fit EdgeOne™ Gutta Percha Points Medium
• 20818365021622: Classic Fit EdgeOne™ Gutta Percha Points Primary
• 20818365021615: Classic Fit EdgeOne™ Gutta Percha Points Small
• 20818365021608: Classic Fit EdgeOne™ Gutta Percha Points Verifile™
• 10818365029560: EdgeOne™ Paper Points Large for EdgeOne Fire™
• 10818365029553: EdgeOne™ Paper Points Medium for EdgeOne Fire™
• 10818365029546: EdgeOne™ Paper Points Primary for EdgeOne Fire™
• 10818365029539: EdgeOne™ Paper Points Small for EdgeOne Fire™
• 10818365029522: EdgeOne™ Gutta Percha Points Large for EdgeOne Fire™
• 10818365029515: EdgeOne™ Gutta Percha Points Medium for EdgeOne Fire™
• 10818365029508: EdgeOne™ Gutta Percha Points Primary for EdgeOne Fire™
• 10818365029492: EdgeOne™ Gutta Percha Points Small for EdgeOne Fire™
• 10818365029485: Slim Fit EdgeOne™ Paper Points Primary
• 10818365029478: Slim Fit EdgeOne™ Paper Points Large
• 10818365029461: Slim Fit EdgeOne™ Gutta Percha Points Small
• 10818365029454: Slim Fit EdgeOne™ Gutta Percha Points Primary
• 10818365029447: Slim Fit EdgeOne™ Gutta Percha Points Medium
• 10818365029430: Slim Fit EdgeOne™ Gutta Percha Points Large
• 10818365029423: Slim Fit EdgeOne™ Paper Points Small
• 10818365027863: Slim Fit EdgeOne™ Paper Points Verifile™
• 10818365027856: Slim Fit EdgeOne™ Paper Points Medium
• 10818365027849: Slim Fit EdgeOne™ Gutta Percha Points Verifile™