MTS

Basic Information

• Brand Name: MTS
• Primary DI: 04260484573001
• Version / Model: LG380
• Catalog Number: 3800000
• Company Name: MTS Medical UG (haftungsbeschränkt)
• Labeler DUNS: 342585299
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2021-06-14
• Public Version Status: Update
• Public Device Record Key: 7def8993-5f84-4022-baf2-0961afdf19d8

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LNS	Lithotriptor, Extracorporeal Shock-Wave,Urological	Gastroenterology, Urology	876.5990	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	4260484573018	GS1	Boc	1	In Commercial Distribution
Primary	04260484573001	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K062081	000

Device Sizes

Type	Value	Unit	Text
Weight	234	Kilogram
Length	1580	Millimeter
Width	1130	Millimeter
Height	1500	Millimeter

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 82 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 82 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 4 – 55 Degrees Celsius