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, for extracorporal shock wave lithotripsy, total energy (12mm) 123mJ, peak pressure (p+) 8 - 126MPa, penetration max. 165mm, focal length F1/F2/F3 (X/YxZ): F1 3,7x30/F2 4,8x32/F3 8,7x63mm, U: 110-120VAC, 50/60Hz, 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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Customer Contact

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+497043350
info@richard-wolf.com
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