EndoPIlot wireless-footswitch, single 109 2361

GUDID 04260482990602

EndoPIlot wireless-footswitch, single

Schlumbohm GmbH & Co. KG

Dental power tool system handpiece, line-powered
Primary Device ID04260482990602
NIH Device Record Key050a19f8-1c2b-4e63-8c89-d4282fd800c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoPIlot wireless-footswitch, single
Version Model Numberbluetooth
Catalog Number109 2361
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
GS104260482990602 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EKXHandpiece, Direct Drive, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

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

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, single2021-06-10EndoPIlot wireless-footswitch, single
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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