FDA.reportPublic FDA data

MTS

Primary DI
04260484573001
Brand
MTS
Company
MTS Medical AG
Model
LG380
Catalog number
3800000
Device description
The LithoGold® is a compact mobile unit for extracorporeal shock wave lithotripsy in urology. Brand Name device: LithoGold® Brand Facility: MTS
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LNSLithotriptor, Extracorporeal Shock-Wave,Urological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNSLithotriptor, Extracorporeal Shock-Wave, UrologicalGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062081000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062081000LITHOGOLDTissue Regeneration Technologies, Inc.2006-11-02LNS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
4260484573018PackageGS11In Commercial Distribution
04260484573001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4260484573018042604845730184260484573018
04260484573001042604845730014260484573001

GMDN Terms#

Term, Definition table
TermDefinition
Spark-gap lithotripsy systemAn 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height1500Millimeter
Length1580Millimeter
Weight234Kilogram
Width1130Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure82 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure82 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature4 Degrees Celsius55 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
342585299
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260484571281ChiroGoldOW100S-US10000292025-06-30
04260484571298ChiroGoldOW100S-US10000292025-06-30
04260484571267Softwave Gold LiOW100S-US10000242024-08-30
04260484571274Softwave Gold LiOW100S-US10000242024-08-30
04260484571601OrthoGold100®OW100-US10000132019-01-23
04260484571687VIASUREOW100-US10000152021-07-01
04260484571823Dermagold100OW100S-US10000222023-09-11
04260484571625OW100SOW100S-US10000212022-11-29
04260484571649DermaGold100®OW100-US10000142020-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974928350131Extracorporeal Shock Wave LithotripterShenzhen Wikkon Precision Technologies Co., Ltd.LNS2025-07-30
08800089800483ASADAL-M1Huons Meditech Co., Ltd.LNS2025-05-26
07630039101442MODULITH®Storz Medical AGLNS2025-04-11
07630039101459MODULITH®Storz Medical AGLNS2025-04-11
07630039101466MODULITH®Storz Medical AGLNS2025-04-11
06975438931018Extracorporeal Shock Wave LithotripterSuzhou Xixin Medical Instruments Co., Ltd.LNS2023-12-25
04049957006464Dornier Delta III Dornier MedTech GmbHLNS2023-03-24
04049957006471Dornier Delta III Dornier MedTech GmbHLNS2023-03-24
07630039100919MODULITH®Storz Medical AGLNS2021-04-13
00810000980475PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980482PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980499PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980505PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980512PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980529PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980536PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980543PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980550PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980567PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980574PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980581PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980598PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980604PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980611PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980628PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980635PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980642PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980659PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980666PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980673PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29