DEVICE: RIWOLITH (04055207038055)

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Device Identifier (DI) Information

RIWOLITH
2280093
2280.093
Richard Wolf GmbH
04055207038055
GS1
3
PROBE 9FR WL 474MM PACK=3 PCS, sterile, for single use
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Electrohydraulic lithotripsy system An assembly of devices that uses plasma-induced shock waves for the intracorporeal fragmentation of stones (calculi) found in the kidney, ureter, and bladder. It typically comprises a generator-powered probe which fires energy pulses at the stone's centre while the probe is irrigated with a saline solution. The collapse of the resulting plasma bubble causes a hydraulic shock that fragments the stone into several pieces which can then be removed using surgical instruments (e.g., a grasping instrument or stone basket).
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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

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 5 and 30 Degrees Celsius
Storage Environment Humidity: between 0 and 70 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
Length: 474 Millimeter
Outer Diameter: 3 Millimeter
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Device Status

In Commercial Distribution
June 28, 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: 04055207049761 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+497043350
info@richard-wolf.com
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