Primary Device ID | 10810047645457 |
NIH Device Record Key | 4cb306a3-018b-4fba-ae8e-7e4f3de49f7d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EdgeSequel Utopia |
Version Model Number | ES400425SE |
Catalog Number | ES400425SE |
Company DUNS | 061317427 |
Company Name | US ENDODONTICS, LLC |
Device Count | 6 |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810047645450 [Primary] |
GS1 | 10810047645457 [Unit of Use] |
EKS | FILE, PULP CANAL, ENDODONTIC |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-08-07 |
Device Publish Date | 2023-07-28 |
10810047645648 | Sterile Endodontic Rotary File |
10810047645631 | Sterile Endodontic Rotary File |
10810047645624 | Sterile Endodontic Rotary File |
10810047645617 | Sterile Endodontic Rotary File |
10810047645600 | Sterile Endodontic Rotary File |
10810047645594 | Sterile Endodontic Rotary File |
10810047645587 | Sterile Endodontic Rotary File |
10810047645570 | Sterile Endodontic Rotary File |
10810047645563 | Sterile Endodontic Rotary File |
10810047645556 | Sterile Endodontic Rotary File |
10810047645549 | Sterile Endodontic Rotary File |
10810047645532 | Sterile Endodontic Rotary File |
10810047645525 | Sterile Endodontic Rotary File |
10810047645518 | Sterile Endodontic Rotary File |
10810047645501 | Sterile Endodontic Rotary File |
10810047645495 | Sterile Endodontic Rotary File |
10810047645488 | Sterile Endodontic Rotary File |
10810047645471 | Sterile Endodontic Rotary File |
10810047645464 | Sterile Endodontic Rotary File |
10810047645457 | Sterile Endodontic Rotary File |
10810047645440 | Sterile Endodontic Rotary File |
10810047645433 | Sterile Endodontic Rotary File |
10810047645426 | Sterile Endodontic Rotary File |
10810047645419 | Sterile Endodontic Rotary File |
10810047645402 | Sterile Endodontic Rotary File |
10810047645396 | Sterile Endodontic Rotary File |
10810047645389 | Sterile Endodontic Rotary File |
10810047645372 | Sterile Endodontic Rotary File |
10810047645365 | Sterile Endodontic Rotary File |
10810047645358 | Sterile Endodontic Rotary File |