DEVICE: LithoClast (07613353000356)

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Device Record History
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Device Identifier (DI) Information
LithoClast
FR-094
In Commercial Distribution
M0068407200
E.M.S. Electro Medical Systems S.A.
07613353000356
GS1

1
481233849 *Terms of Use
Pneumatic Handpiece Kit
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
47098 Pneumatic lithotripsy system handpiece
A hand-held component of a pneumatic intracorporeal lithotripsy system designed to hold the system's ballistic probe (i.e., it forms a handle around the probe) and is connected via a dedicated cable to the system's control unit from which energy is transmitted. The handpiece includes connectors and is typically made of metal [e.g., stainless steel, aluminium (Al)] and plastic materials. It may also facilitate suction used for the removal of the fragmented calculi. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FFK Lithotriptor, Electro-Hydraulic
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K012445 000
No CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
182af3f4-3813-45a2-bfb7-10b3b16446bd
September 24, 2018
4
September 01, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+41229944700
udi@ems-ch.com
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