FDA.report

LITHOCLAST

Primary DI
07613353125912
Brand
LITHOCLAST
Company
E.M.S. Electro Medical Systems S.A.
Model
A
Catalog number
DW-047B
Device description
Cart for Swiss LithoClast Trilogy
Published
2019-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FEOLithotriptor, Ultrasonic

Product Code Classifications

CodeDeviceSpecialtyClass
FEOLithotriptor, UltrasonicGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07613353125912PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613353125912076133531259127613353125912

GMDN Terms

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.

Device Sizes

TypeValueUnit
Weight23.5Kilogram

Sterilization Methods

Method

Contacts

PhoneEmail
+41229944700udi@ems-ch.com

Regulatory Flags

DUNS number
481233849
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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07613353347802GBT Machine AIRFLOW Prophylaxis MasterFT-300FT-300 2B 3022026-02-16
07613353347819GBT Machine AIRFLOW Prophylaxis MasterFT-300FT-300 2BV022026-02-16
07613353348137AIR-FLOWFS-474FS-474/MX2026-02-16
04262477320197SONOGELDV-1552025-09-02
07613353334932AIR-FLOWFS-474FS-474/MX2025-07-07
07613353342067AIR-FLOWEL-308#MX2025-07-07
07613353342074AIR-FLOWEL-354#MX2025-07-07
07613353343965AIR-FLOWFS-477/USFS-477/US/MX2025-07-07
07613353337353PIEZONDS-001A/B2025-06-10
07613353337360PIEZONDS-001A/T/A2025-06-10
07613353337377PIEZONDS-011A/B2025-06-10
07613353337438PIEZONDS-010A/B2025-06-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07613353125929LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2024-09-03
00821925043787SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043794SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043800SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043824SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043725SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043732SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043749SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043756SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043763SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043817OlympusGyrus Acmi, Inc.FEO2024-07-23
04953170026782Probe uncologging rodOLYMPUS MEDICAL SYSTEMS CORP.FEO2021-12-18
04953170318818Probe for LUS-2 2.0mm O.D.OLYMPUS MEDICAL SYSTEMS CORP.FEO2021-12-17
04953170026799Probe uncologging rodOLYMPUS MEDICAL SYSTEMS CORP.FEO2021-12-16
00821925043671ShockPulseGyrus Acmi, Inc.FEO2020-03-03
00821925043688ShockPulseGyrus Acmi, Inc.FEO2020-03-03
00821925043695ShockPulseGyrus Acmi, Inc.FEO2020-03-03
00821925043701ShockPulseGyrus Acmi, Inc.FEO2020-03-03
00821925043718ShockPulseGyrus Acmi, Inc.FEO2020-03-03
00821925044203ShockPulseGyrus Acmi, Inc.FEO2020-03-03
00821925043831ShockPulseGyrus Acmi, Inc.FEO2020-03-02
00821925044197ShockPulseGyrus Acmi, Inc.FEO2020-03-02
00821925039445SHOCKPULSE LITHOTRIPSY WRENCHGyrus Acmi, Inc.FEO2018-09-14
07613353156114LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2018-09-03
07613353156121LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2018-09-03
07613353157982LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2018-08-31
07613353162559LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2018-08-31
07613353162566LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2018-08-31
07613353162573LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2018-08-31
07613353162580LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2018-08-31