DEVICE: US-LITHO (04055207023105)
Device Identifier (DI) Information
US-LITHO
8959515
Not in Commercial Distribution
8959.515
Richard Wolf GmbH
8959515
Not in Commercial Distribution
8959.515
Richard Wolf GmbH
SONOTRODE Ø 1.5MM WL 444MM straight, exchangeable, reusable
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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No | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35712 | 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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FFK | Lithotriptor, electro-hydraulic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Outer Diameter: 1.5 Millimeter |
Length: 444 Millimeter |
Device Record Status
414ac104-84eb-4da5-923b-916d3c15bcc2
February 29, 2024
7
September 23, 2016
February 29, 2024
7
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+497043350
info@richard-wolf.com
info@richard-wolf.com