DEVICE: MTS (04260484573001)
Device Identifier (DI) Information
MTS
LG380
In Commercial Distribution
3800000
MTS Medical UG (haftungsbeschränkt)
LG380
In Commercial Distribution
3800000
MTS Medical UG (haftungsbeschränkt)
The LithoGold® is a compact mobile unit for extracorporeal shock wave lithotripsy in urology.
Brand Name device: LithoGold®
Brand Facility: MTS
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
18417 | Spark-gap 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 spark-gap generator. The generator delivers shock waves when an electrical discharge between two electrodes submerged in water or in electrolytes causes explosive vaporization; the shock wave expands from the gap between the electrodes and is focused at the stone by an ellipsoidal reflector. 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
[?]Product Code | Product Code Name |
---|---|
LNS | Lithotriptor, Extracorporeal Shock-Wave,Urological |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K062081 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Atmospheric Pressure: between 82 and 106 KiloPascal |
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity |
Handling Environment Temperature: between 10 and 35 Degrees Celsius |
Storage Environment Atmospheric Pressure: between 82 and 106 KiloPascal |
Storage Environment Humidity: between 10 and 85 Percent (%) Relative Humidity |
Storage Environment Temperature: between 4 and 55 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Weight: 234 Kilogram |
Length: 1580 Millimeter |
Width: 1130 Millimeter |
Height: 1500 Millimeter |
Device Record Status
7def8993-5f84-4022-baf2-0961afdf19d8
June 14, 2021
5
September 24, 2016
June 14, 2021
5
September 24, 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 |
---|---|---|---|---|---|
4260484573018 | 1 | 04260484573001 | In Commercial Distribution | Boc |
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
[?]
(404) 402-6844
info@trtllc.com
info@trtllc.com