Swiss DolorClast

GUDID 07613353077464

Swiss DolorClast

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

Pneumatic orthopaedic extracorporeal shock wave therapy system
Primary Device ID07613353077464
NIH Device Record Key09a0aebf-4fcf-4653-a289-b666bc9e9fea
Commercial Distribution StatusIn Commercial Distribution
Brand NameSwiss DolorClast
Version Model NumberFT-183#A/001
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 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

Customer Support Contacts

Phone+41229944700
Emailwelcome@ems-ch.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107613353077464 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NBNGenerator, Shock-Wave, For Pain Relief

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-09-03
Device Publish Date2018-06-22

On-Brand Devices [Swiss DolorClast]

07613353077464Swiss DolorClast
07613353000066Gel bottle
07613353000059Pneumatic foot pedal
07613353000042Applicator Ø15mm
07613353000035Handpiece DolorClast
07613353000028Handpiece kit DolorClast
07613353000011Swiss DolorClast
07613353181284Handpiece DolorClast
07613353170264Gel bottle
07613353194895Cart StackUp
04260153472031Gel bottle
07613353226053DolorClast Radial
07613353187101Compact Cart DolorClast

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