DEVICE: Calcusplit (04048551086278)

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Device Identifier (DI) Information

Calcusplit
27630038

Karl Storz GmbH & Co. KG
04048551086278
GS1
1
CALCUSPLIT Handpiece
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Electromechanical lithotripsy system, intracorporeal An assembly of devices designed to create shock waves through electromechanical action for the intracorporeal fragmentation of calculi (stones) in the urinary tract (i.e., kidney, ureter and bladder); the resulting debris may be actively removed or passed out by natural means at a later date. The energy is generated by an integral drive unit which converts electrical energy into mechanical force. The force is applied to an impact hammer that strikes the proximal end of a lithotripsy system probe which is brought into physical contact with the stone to be fragmented, therefore providing high-speed fragmentation of the calculus in situ.
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FDA Product Code

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Product Code Product Code Name
FFK Lithotriptor, electro-hydraulic
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 23, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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