AIR-FLOW - PIEZON EK-169

GUDID 07613353113049

Multifunction foot pedal

E.M.S. Electro Medical Systems S.A.

Foot-switch, electrical
Primary Device ID07613353113049
NIH Device Record Keya22ea2c6-42d9-49ba-9df7-e676f5fd2b0c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIR-FLOW - PIEZON
Version Model Numberd
Catalog NumberEK-169
Company DUNS481233849
Company NameE.M.S. Electro Medical Systems S.A.
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+41229944700
Emailudi@ems-ch.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107613353113049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EFBHandpiece, Air-Powered, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-16

Devices Manufactured by E.M.S. Electro Medical Systems S.A.

07613353337353 - PIEZON2025-06-18 Instrument A with combitorque
07613353337360 - PIEZON2025-06-18 Instrument A x3
07613353337377 - PIEZON2025-06-18 Instrument P with combitorque
07613353337438 - PIEZON2025-06-18 Complete PI instrument holder
07613353337445 - PIEZON2025-06-18 Instrument P x3
07613353337452 - PIEZON2025-06-18 Instrument PS with combitorque
07613353337469 - PIEZON2025-06-18 Instrument PS x3
07613353337476 - PIEZON2025-06-18 Instr. PSL with combitorque

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