| Primary Device ID | 10818365020642 |
| NIH Device Record Key | fc8103de-ee7b-4405-9150-0b027e4bb34a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EdgeOne Fire™ |
| Version Model Number | MEOFLGPP |
| Catalog Number | MEOFLGPP |
| 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 | 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 |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com | |
| Phone | +1(423)283-0047 |
| Bobby.bennett@us-endo.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00818365020645 [Primary] |
| GS1 | 10818365020642 [Unit of Use] |
| EKN | POINT, PAPER, ENDODONTIC |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-03 |
| Device Publish Date | 2023-06-25 |
| 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 |