MTS 3800000

GUDID 4260484573018

The LithoGold® is a compact mobile unit for extracorporeal shock wave lithotripsy in urology. Brand Name device: LithoGold® Brand Facility: MTS

MTS Medical UG (haftungsbeschränkt)

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Primary Device ID	4260484573018
NIH Device Record Key	7def8993-5f84-4022-baf2-0961afdf19d8
Commercial Distribution Status	In Commercial Distribution
Brand Name	MTS
Version Model Number	LG380
Catalog Number	3800000
Company DUNS	342585299
Company Name	MTS Medical UG (haftungsbeschränkt)
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Customer Support Contacts

Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com

Device Dimensions

Height	1500 Millimeter
Height	1500 Millimeter
Height	1500 Millimeter
Height	1500 Millimeter
Weight	234 Kilogram
Length	1580 Millimeter
Width	1130 Millimeter
Height	1500 Millimeter
Weight	234 Kilogram
Length	1580 Millimeter
Width	1130 Millimeter
Height	1500 Millimeter
Weight	234 Kilogram
Length	1580 Millimeter
Width	1130 Millimeter
Height	1500 Millimeter
Weight	234 Kilogram
Length	1580 Millimeter
Width	1130 Millimeter
Height	1500 Millimeter
Weight	234 Kilogram
Length	1580 Millimeter
Width	1130 Millimeter
Height	1500 Millimeter
Weight	234 Kilogram
Length	1580 Millimeter
Width	1130 Millimeter
Height	1500 Millimeter
Weight	234 Kilogram
Length	1580 Millimeter
Width	1130 Millimeter
Height	1500 Millimeter
Weight	234 Kilogram
Length	1580 Millimeter
Width	1130 Millimeter
Height	1500 Millimeter
Weight	234 Kilogram
Length	1580 Millimeter
Width	1130 Millimeter
Height	1500 Millimeter
Weight	234 Kilogram
Length	1580 Millimeter
Width	1130 Millimeter
Height	1500 Millimeter
Weight	234 Kilogram
Length	1580 Millimeter
Width	1130 Millimeter
Height	1500 Millimeter
Weight	234 Kilogram
Length	1580 Millimeter
Width	1130 Millimeter
Height	1500 Millimeter
Weight	234 Kilogram
Length	1580 Millimeter
Width	1130 Millimeter
Height	1500 Millimeter
Weight	234 Kilogram
Length	1580 Millimeter
Width	1130 Millimeter
Height	1500 Millimeter
Weight	234 Kilogram
Length	1580 Millimeter
Width	1130 Millimeter
Height	1500 Millimeter
Weight	234 Kilogram
Length	1580 Millimeter
Width	1130 Millimeter
Height	1500 Millimeter

Operating and Storage Conditions

Storage Environment Temperature	Between 4 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 4 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 4 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 4 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 4 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 4 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 4 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 4 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 4 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 4 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 4 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 4 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 4 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 4 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 4 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 4 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 4 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260484573001 [Primary]
GS1	4260484573018 [Package] Contains: 04260484573001 Package: Boc [1 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K062081

FDA Product Code

LNS	Lithotriptor, Extracorporeal Shock-Wave,Urological

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2020-04-01
Device Publish Date	2016-09-24

Devices Manufactured by MTS Medical UG (haftungsbeschränkt)

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04260484571694 - VIASURE	2021-07-09 Indications for Use The VIASURE is intended for : • Relief of minor muscle aches and pains • Temporary increase in local blo
04260484571649 - DermaGold100®	2020-04-08 The DermaGold100® is intended for treatment of diabetic footulcers
4260484573018 - MTS	2020-04-01The LithoGold® is a compact mobile unit for extracorporeal shock wave lithotripsy in urology. Brand Name device: LithoGold® Brand Facility: MTS
4260484573018 - MTS	2020-04-01 The LithoGold® is a compact mobile unit for extracorporeal shock wave lithotripsy in urology. Brand Name device: LithoGold®
04260484571618 - OrthoGold100®	2019-02-25 The OrthoGold100® is intended for the activation of connective tissue.