DEVICE: PIEZOLITH (04055207056950)

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Device Identifier (DI) Information

PIEZOLITH
3000002
3000.002
Richard Wolf GmbH
04055207056950
GS1
1
LITHOTRIPTER 3000 for stone fragmentation of renal hollow system (renal pelvis and calyces) and in the upper, middle and lower ureter, Total energy (12mm) , peak pressure (p+) 8-126, penetration max. 165mm, F1 3.7x30. F2 4.8x32. F3 8.7x63mm, U: 110-120VAC, 50/60 Hz, Dim. (wxhxd): 720x1000x1200mm
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Device Characteristics

Labeling does not contain MRI Safety Information
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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
Piezoelectric lithotripsy system An assembly of devices that non-invasively disintegrates stones (i.e., calculi) by sending focused shock waves from outside the body produced by a piezoelectric generator. This generator contains an array of up to 4,000 ceramic elements arranged on a spherical dish; shock waves are generated at the focal point of the dish when a short, high-voltage pulse is simultaneously applied to each element. This system also includes a treatment table, an imaging system, and an operator's console. This [extracorporeal shock wave lithotripsy (ESWL)] system is used to disintegrate stones located in the kidneys, urinary tract, gallbladder, or bile/pancreatic ducts.
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FDA Product Code

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Product Code Product Code Name
LNS Lithotriptor, extracorporeal shock-wave,urological
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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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
July 21, 2017

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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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None
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Production Identifier(s) in UDI

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Yes
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Customer Contact

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+497043350
info@richard-wolf.com
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