FDA.report

LithoClast

Primary DI
07613353002855
Brand
LithoClast
Company
E.M.S. Electro Medical Systems S.A.
Model
FR-199B
Catalog number
M006840735
Device description
Rigid Pneumatic Probe 1.6mm x 453mm
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
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FFKLithotriptor, Electro-Hydraulic

Product Code Classifications

CodeDeviceSpecialtyClass
FFKLithotriptor, Electro-HydraulicGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07613353002855PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613353002855076133530028557613353002855

GMDN Terms

TermDefinition
Ultrasonic lithotripsy system reusableA slender, metal, tubular device that is coaxially attached to an ultrasonic lithotripsy system handpiece [a hand-held acoustic transducer that produces ultrasound (US) waves] and intended to transmit US waves to calculi (stones) in the urinary tract (i.e., kidneys, ureters, and bladder) for their fragmentation. Its distal end is brought into contact with calculi and transmits the energy, breaking down the calculi in the body for removal through its lumen. This device is introduced through the working channel of an appropriate endoscope (e.g., a percutaneous nephroscope for ureteral stones). This is a reusable device intended to be sterilized prior to use.

Device Sizes

TypeValueUnit
Length453Millimeter
Outer Diameter1.6Millimeter

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
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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