Primary Device ID | 10818365020482 |
NIH Device Record Key | dd2f5362-f74a-4e5a-adbf-86c6598e409f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EdgeTaper Platinum™ |
Version Model Number | METF1GP |
Catalog Number | METF1GP |
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 |
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 | 00818365020485 [Primary] |
GS1 | 10818365020482 [Unit of Use] |
EKM | GUTTA-PERCHA |
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 |
10818365020758 | EdgeTaper Platinum™ Bioceramic Gutta Percha Points F5 |
10818365020741 | EdgeTaper Platinum™ Bioceramic Gutta Percha Points F4 |
10818365020734 | EdgeTaper Platinum™ Bioceramic Gutta Percha Points F3 |
10818365020727 | EdgeTaper Platinum™ Bioceramic Gutta Percha Points F2 |
10818365020710 | EdgeTaper Platinum™ Bioceramic Gutta Percha Points F1 |
10818365020574 | MIS EdgeTaper Paper Points F5 |
10818365020567 | MIS EdgeTaper Paper Points F4 |
10818365020550 | MIS EdgeTaper Paper Points F3 |
10818365020543 | MIS EdgeTaper Paper Points F2 |
10818365020536 | MIS EdgeTaper Paper Points F1 |
10818365020529 | MIS EdgeTaper Gutta Percha Points F5 |
10818365020512 | MIS EdgeTaper Gutta Percha Points F4 |
10818365020505 | MIS EdgeTaper Gutta Percha Points F3 |
10818365020499 | MIS EdgeTaper Gutta Percha Points F2 |
10818365020482 | MIS EdgeTaper Gutta Percha Points F1 |