FDA.report

LithoClast

Primary DI
07613353000530
Brand
LithoClast
Company
E.M.S. Electro Medical Systems S.A.
Model
EL-379B
Catalog number
M0068403070
Device description
Combination suction connector BSC
Published
2016-09-01
Public version status
Update
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
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered

Product Code Classifications

CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07613353000530PrimaryGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorEAN-13Conversion note
07613353000530140761335300053007613353000530Indicator 0 allows EAN-13 conversion; UPC-A requires prefix 00.

GMDN Terms

TermDefinition
Pneumatic/ultrasonic lithotripsy systemAn assembly of devices that uses a combination of, or individually applied, pneumatically-created ballistic shock waves and ultrasonic waves for the intracorporeal fragmentation of stones (calculi) in the urinary tract (i.e., kidney, ureter, and bladder) for their removal. It typically includes a pressure and power regulator/control unit, handpieces, and two types of probes of various sizes. The probes are attached to the two handpieces which are connected to the control unit that supplies the energy for both the pneumatic and ultrasonic functions. Energy is applied to a calculus which is fragmented in situ and removed via a suction system facilitated by the lithotripsy system.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
true
Serial number
false
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
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07613353180089Instruments A P PSFS-4582026-02-16
07613353180096Instruments PS PSR PSLFS-4592026-02-16
07613353225940GBT FLOWCONTROL x 4FV-112/A2026-02-16
07613353313500GBT Machine StationDW-1002026-02-16
07613353331184GBT Machine Wireless PedalEK-1055B2026-02-16
07613353334925AIR-FLOWFS-465FS-465/MX2026-02-16
07613353335847AIR-FLOWFS-477/US2026-02-16
07613353336837Instruments PSR PSLFS-4612026-02-16
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
00653405014952POOLEConmed CorporationGCX2026-03-24
50198956355475CARDINAL HEALTHCardinal Health 200, LLCGCX2026-03-19
50198956417999CARDINAL HEALTHCardinal Health 200, LLCGCX2026-03-16
G8057116571Bleed IDAPARATA MEDICAL, LLCGCX2026-03-02
50198956375640CARDINAL HEALTHCardinal Health 200, LLCGCX2026-02-13
50198956277937CARDINAL HEALTHCardinal Health 200, LLCGCX2026-01-22
20889483228743Muc-Away™SUNMED, LLCGCX2025-12-31
20889483228750Muc-Away™SUNMED, LLCGCX2025-12-31
20889483230111Muc-Away™SUNMED, LLCGCX2025-12-31
10889483230121Muc-Away™SUNMED, LLCGCX2025-12-31
50198956261806CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-17
50192253043363CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50192253043370CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50192253043387CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50192253043394CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50192253043400CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50192253043417CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50198956252125CARDINAL HEALTHCardinal Health 200, LLCGCX2025-11-25
20816286021189Boehringer Surgical Suction DeviceBOEHRINGER LABORATORIES, LLCGCX2025-11-24
50198956160857CARDINAL HEALTHCardinal Health 200, LLCGCX2025-08-27
50198956180381CARDINAL HEALTHCardinal Health 200, LLCGCX2025-08-27
00194613008253MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613019945MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613019952MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021504MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021511MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021627MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021634MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021641MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021665MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01