DEVICE: n.a. (04048551395264)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
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Ultrasonic lithotripsy system | An assembly of devices designed to use ultrasonic (US) shock waves for the intracorporeal fragmentation of stones (calculi) found in the kidney, ureter, and bladder. This system can have a variety of configurations and will typically employ endoscopic devices together with a dedicated US transducer and probe (e.g., a sonotrode) during its application. The debris may be forcefully removed (e.g., through irrigation/suction) or passed out by natural means at a later date. |
FDA Product Code
[?]Product Code | Product Code Name |
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FEO | Lithotriptor, ultrasonic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K843101 | 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
e6165805-b60f-4206-8ea0-fcfb9719faba
July 06, 2018
3
September 23, 2016
July 06, 2018
3
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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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
[?]
No Customer Contact currently defined