FDA.reportPublic FDA data

LithoClast

Primary DI
07613353000554
Brand
LithoClast
Company
E.M.S. Electro Medical Systems S.A.
Model
FR-163
Catalog number
M0068403160
Device description
Combination suction connector Ø8
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613353000554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613353000554076133530005547613353000554

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic lithotripsy systemAn assembly of devices (not all hand-held) designed to use pneumatically-created ballistic shock waves for the intracorporeal fragmentation of urinary tract calculi (stones) in the kidney, ureter, and bladder. It typically includes an electronic pressure regulator/control unit, a handpiece, probes of various sizes, and a foot-switch. A probe is attached to the handpiece which is connected to the control unit, which uses compressed air to provide the pressure pulses that propagate to the distal tip of the probe for energy transmission. Working through an appropriate endoscope, this energy is applied to a calculus for fragmentation in situ and subsequent removal using suction.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
481233849
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

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