AIR-FLOW-PIEZON FS-338/B

GUDID 07613353002909

AIR-FLOW MASTER PIEZON System Blue

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

Ultrasonic dental scaling/debridement system
Primary Device ID07613353002909
NIH Device Record Keydd98d705-32d0-4ba6-848c-2fc4024c88b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIR-FLOW-PIEZON
Version Model Numberd
Catalog NumberFS-338/B
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
GS107613353002909 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELCScaler, Ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07613353002909]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-01

On-Brand Devices [AIR-FLOW-PIEZON]

07613353172381Air-Flow Master Piezon
07613353172374Air-Flow Master Piezon
07613353172367Air-Flow Master Piezon
07613353172312AIR-FLOW S2
07613353172305AIR-FLOW S2
07613353172299AIR-FLOW S2
07613353167875Air-Flow Master Piezon
07613353167868Air-Flow Master Piezon
07613353167851Air-Flow Master Piezon
07613353167806AIR-FLOW S2
07613353167790AIR-FLOW S2
07613353167783AIR-FLOW S2
07613353115517AIR-FLOW S2
07613353096724Basic Air-Flow Master Piezon
07613353096687Air-Flow Master Piezon
07613353096670Air-Flow Master Piezon
07613353077358AIR-FLOW S2
07613353077341AIR-FLOW S2
07613353060541Multifunction foot pedal
07613353002916AIR-FLOW MASTER PIEZON System White
07613353002909AIR-FLOW MASTER PIEZON System Blue
07613353002893AIR-FLOW MASTER PIEZON System Grey
07613353002732AIR-FLOW S2
07613353002725AIR-FLOW S2 basic
07613353002404Basic Air-Flow Master Piezon
07613353002398AIR-FLOW MASTER PIEZON System White
07613353060510Multifunction foot pedal
07613353196448Air abrasion piezo-ceramic
07613353184124Air abrasion piezo ceramic
07613353157968Air abrasion piezo-ceramic
07613353132859AIRFLOW Station+
07613353134327AIRFLOW Station
07613353123017Boost wireless pedal
07613353123000Foot switch
07613353195229AIRFLOW Prophylaxis Master
07613353187378AIRFLOW Prophylaxis Master unit
07613353161958AIRFLOW Prophylaxis Master basic
07613353199739AIRFLOW Prophylaxis Master
07613353212636AIRFLOW Prophylaxis Master
07613353213176AIRFLOW Prophylaxis Master
07613353185343AIRFLOW Station
07613353214432AIRFLOW Prophylaxis Master

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