DEVICE: LITHOCLAST (07613353151843)
Device Identifier (DI) Information
LITHOCLAST
B
In Commercial Distribution
FR-089#A/001
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution
FR-089#A/001
E.M.S. Electro Medical Systems S.A.
Pneumatic handpiece pn3 kit
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FFK | Lithotriptor, Electro-Hydraulic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K963285 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
5f7e95b4-9c65-4e54-b13c-8e09a7ec4299
September 15, 2021
1
September 07, 2021
September 15, 2021
1
September 07, 2021
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+41229944700
udi@ems-ch.com
udi@ems-ch.com