DEVICE: US-LITHO (04055207012161)

Device Identifier (DI) Information

US-LITHO
2271501
In Commercial Distribution
2271.501
Richard Wolf GmbH
04055207012161
GS1

1
315304071 *Terms of Use
TRANSDUCER Ø 28.5MM WL 145MM
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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No
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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
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.
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FDA Product Code

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Product Code Product Code Name
FFK Lithotriptor, electro-hydraulic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K011065 000
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Sterilization

No
No
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
Length: 145 Millimeter
Outer Diameter: 28.5 Millimeter
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Device Record Status

072cf26f-c137-4d28-90b3-20743aa42488
July 06, 2018
3
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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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
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Customer Contact

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+497043350
info@richard-wolf.com
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