Instrument PI starter kit FS-295#

GUDID 07613353086749

Instrument PI starter kit

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

Ultrasonic dental scaling/debridement system
Primary Device ID07613353086749
NIH Device Record Key97c0a0ab-1260-438e-96f5-c994a61e4f02
Commercial Distribution StatusIn Commercial Distribution
Brand NameInstrument PI starter kit
Version Model NumberFS-295#
Catalog NumberFS-295#
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
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107613353086749 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELCScaler, Ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


[07613353086749]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-04
Device Publish Date2024-11-26

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