FDA.reportPublic FDA data

SWISS DOLORCLAST

Primary DI
07613353194895
Brand
SWISS DOLORCLAST
Company
E.M.S. Electro Medical Systems S.A.
Model
DW-044
Device description
Cart StackUp
Published
2020-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NBNGenerator, Shock-Wave, For Pain Relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBNGenerator, Shock-Wave, For Pain ReliefUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P050004000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P050004000EMS SWISS DOLORCLASTElectro Medical Systems (Ems Sa)2007-05-08NBN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613353194895PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613353194895076133531948957613353194895

GMDN Terms#

Term, Definition table
TermDefinition
Electromechanical device/system transport trolleyA mobile (on wheels) cart intended to be used as a carrier for transporting an electromechanical device(s) or a powered system assembly. This trolley (cart) may be designed specifically for a proprietary control unit/system, and will typically have one or more horizontal surfaces where the devices are placed; it may include additional features (e.g., gas cylinder holder, intravenous pole) specific to a proprietary system. Neither electromechanical devices nor system components are included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41229944700udi@ems-ch.com

Regulatory Flags#

DUNS number
481233849
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613353028374PIEZONDS-001OS2026-07-13
07613353170318PIEZONDS-011A/A2026-07-13
07613353170325PIEZONDS-016OS2026-07-13
07613353171582AIR-FLOW-PIEZONDW-048ADW-048A2026-07-13
07613353223182PIEZONDS-010A2026-07-13
07613353225117PIEZONDT-065ADT-065A/A2026-07-13
07613353343965AIR-FLOWFS-477/USFS-477/US/MX2025-07-07
07613353336790Instrument PI starter kitFS-295#FS-295#2025-04-23
07613353313500GBT Machine StationDW-1002026-02-16
07613353337476PIEZONDS-083A/B2025-06-10
07613353337490PIEZONDS-084A/B2025-06-10
07613353179557PIEZONDS-001A/T2019-12-13
07613353183493PIEZONDS-011A/T2019-12-13
07613353183486PIEZONDS-011A/A2019-12-11
07613353183523PIEZONDS-016A/A2019-12-11
07613353183769PIEZONDS-083A/A2019-12-11
07613353183776PIEZONDS-083A/T2019-12-11
07613353183783PIEZONDS-084A/A2019-12-11
07613353183790PIEZONDS-084A/T2019-12-11
07613353179199PIEZONDS-001A/A2019-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630039101404DUOLITH®Storz Medical AGNBN2021-06-29
04260153472031Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2021-06-02
07630039101398DUOLITH®Storz Medical AGNBN2021-04-08
07613353170264Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2020-06-03
07630039101312CHATTANOOGAStorz Medical AGNBN2020-03-23
07630039101329DUOLITH®Storz Medical AGNBN2020-03-23
07630039101336DUOLITH®Storz Medical AGNBN2020-03-23
07613353181284Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2019-10-16
07613353077464Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2018-06-22
07630039101022CHATTANOOGAStorz Medical AGNBN2018-05-28
07290016498417OrthospecMEDISPEC LTD.NBN2017-06-22
07630039100827CHATTANOOGAStorz Medical AGNBN2017-01-16
07630039100759CHATTANOOGAStorz Medical AGNBN2016-06-27
07630039100773DUOLITH®Storz Medical AGNBN2016-06-27
07613353000011Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2015-11-04
07613353000028Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2015-11-04
07613353000042Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2015-11-04
07613353000059Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2015-11-04
07613353000066Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2015-11-04
07613353000035Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2015-10-26