DEVICE: MTS (04260484573001)

Device Identifier (DI) Information

MTS
LG380
In Commercial Distribution

MTS Medical UG (haftungsbeschränkt)
04260484573001
GS1

1
342585299 *Terms of Use
The LithoGold® is a compact mobile unit for extracorporeal shock wave lithotripsy in urology.
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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
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

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Product Code Product Code Name
LNS Lithotriptor, Extracorporeal Shock-Wave,Urological
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K062081 000
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Sterilization

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

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Storage and Handling
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
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Clinically Relevant Size

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Size Type Text
Weight: 234 Kilogram
Length: 1580 Millimeter
Width: 1130 Millimeter
Height: 1500 Millimeter
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Device Record Status

7def8993-5f84-4022-baf2-0961afdf19d8
July 06, 2018
3
September 24, 2016
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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
4260484573018 1 04260484573001 In Commercial Distribution Boc
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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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Yes
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
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Customer Contact

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(404) 402-6844
info@trtllc.com
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