EndoPilot apex cable set 109 2311

GUDID 04260482990282

Apex-cable-Set for Endopilot, consist of: 1x measuring cable with plug; 1x lip clip; 1x cap for lip contact; 1x cable for file clamp; 1x file clamp, dismountable; 1x Bushing for lip-clip cable-socket

Schlumbohm GmbH & Co. KG

Endodontic apex locator
Primary Device ID04260482990282
NIH Device Record Key2384df8d-de39-4857-bba0-0a1df5d95d78
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoPilot apex cable set
Version Model NumberEDP2
Catalog Number109 2311
Company DUNS343831731
Company NameSchlumbohm GmbH & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260482990282 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LQYLocator, Root Apex

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04260482990282]

High-level Disinfectant;Moist Heat or Steam Sterilization


[04260482990282]

High-level Disinfectant;Moist Heat or Steam Sterilization


[04260482990282]

High-level Disinfectant;Moist Heat or Steam Sterilization


[04260482990282]

High-level Disinfectant;Moist Heat or Steam Sterilization


[04260482990282]

High-level Disinfectant;Moist Heat or Steam Sterilization


[04260482990282]

High-level Disinfectant;Moist Heat or Steam Sterilization


[04260482990282]

High-level Disinfectant;Moist Heat or Steam Sterilization


[04260482990282]

High-level Disinfectant;Moist Heat or Steam Sterilization


[04260482990282]

High-level Disinfectant;Moist Heat or Steam Sterilization


[04260482990282]

High-level Disinfectant;Moist Heat or Steam Sterilization


[04260482990282]

High-level Disinfectant;Moist Heat or Steam Sterilization


[04260482990282]

High-level Disinfectant;Moist Heat or Steam Sterilization


[04260482990282]

High-level Disinfectant;Moist Heat or Steam Sterilization


[04260482990282]

High-level Disinfectant;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-08
Device Publish Date2021-05-31

Devices Manufactured by Schlumbohm GmbH & Co. KG

04260482990824 - Extension set ultrasonic for EndoPilot2022-09-05 Extension set ultrasonic for EndoPilot²: consisting of: Ultrasonic module, Ultrasonic handpiece Newtron/ Satelec, Ultrasonic ha
04260482991128 - EndoPilot Obtura set2021-10-22 EndoPilot Obtura expansion set consist of: 1x BackFill Gun Obtura, 1x Obtura Needle Lock Nut, 4x Heat Insulator, 5x Gun-Needl
04260482990190 - EndoPilot D-Pack2021-09-20 Downpack (D-Pack) handpiece for EndoPilot
04260482991135 - EndoPilot DownPack expansion set2021-09-20 EndoPilot DownPack expansion set consist of: D-Pack handpiece, with LED-indicator, Heating-tip size: fine and a D-Pack/Backfil
04260482990084 - EndoPilot Motor2021-06-10 EndoPilot Motor with ISO-E standard; LED-indicator and Apex-contact
04260482990602 - EndoPIlot wireless-footswitch, single2021-06-10 EndoPIlot wireless-footswitch, single
04260482990763 - EndoPilot Control Box, Komet2021-06-10 EndoPilot² Control Box, Komet
04260482990787 - EndoPilot power supply2021-06-10 AC/DC power supply for EndoPilot²

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