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 |