EndoPilot Control Box, Komet 110 2011

GUDID 04260482990763

EndoPilot² Control Box, Komet

Schlumbohm GmbH & Co. KG

Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered
Primary Device ID04260482990763
NIH Device Record Key9e5e9562-7ab1-4261-a8a6-04dc74171d7c
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoPilot Control Box, Komet
Version Model NumberEDP2
Catalog Number110 2011
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 Batchfalse
Serial Numbertrue
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
GS104260482990763 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EKXHandpiece, Direct Drive, Ac-Powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04260482990763]

High-level Disinfectant


[04260482990763]

High-level Disinfectant


[04260482990763]

High-level Disinfectant


[04260482990763]

High-level Disinfectant


[04260482990763]

High-level Disinfectant


[04260482990763]

High-level Disinfectant


[04260482990763]

High-level Disinfectant


[04260482990763]

High-level Disinfectant


[04260482990763]

High-level Disinfectant


[04260482990763]

High-level Disinfectant


[04260482990763]

High-level Disinfectant


[04260482990763]

High-level Disinfectant


[04260482990763]

High-level Disinfectant


[04260482990763]

High-level Disinfectant


[04260482990763]

High-level Disinfectant


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-10
Device Publish Date2021-06-02

Devices Manufactured by Schlumbohm GmbH & Co. KG

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, Komet2021-06-10EndoPilot² Control Box, Komet
04260482990763 - EndoPilot Control Box, Komet2021-06-10 EndoPilot² Control Box, Komet
04260482990787 - EndoPilot power supply2021-06-10 AC/DC power supply for EndoPilot²
04260482990817 - EndoPilot retainer for apexcable2021-06-10 EndoPilot retainer for apexcable
04260482990923 - EndoPilot Cap for lip-contact2021-06-10 EndoPilot Cap for lip-contact
04260482990282 - EndoPilot apex cable set2021-06-08 Apex-cable-Set for Endopilot, consist of: 1x measuring cable with plug; 1x lip clip; 1x cap for lip contact; 1x cable for file c
04260482990305 - EndoPilot Lip-clip2021-06-08 Lip-clip for EndoPilot apex-cable

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