FDA.report

NA

Primary DI
04055207012505
Brand
NA
Company
Richard Wolf GmbH
Model
3000390
Catalog number
3000390
Device description
LITHOARM/SHORT
Published
2017-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
OWBInterventional fluoroscopic x-ray system

Product Code Classifications

CodeDeviceSpecialtyClass
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207012505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207012505040552070125054055207012505

GMDN Terms

TermDefinition
Piezoelectric 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 piezoelectric generator. This generator contains an array of up to 4,000 ceramic elements arranged on a spherical dish; shock waves are generated at the focal point of the dish when a short, high-voltage pulse is simultaneously applied to each element. 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.

Sterilization Methods

Method

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

DUNS number
315304071
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04055207069226NA1006921006922026-03-12
04055207069257NA1006981006982026-03-12
04055207068243VERTEBRIS89250643892506432026-02-10
04055207069691NA8922090328922090322026-02-10
04055207069707NA8922090228922090222026-02-10
04055207069714NA8922090238922090232026-02-10
04055207069721NA8922090338922090332026-02-10
04055207069738NA89220922892209222026-02-10
04055207069745NA89220923892209232026-02-10
04055207069790NA8924084158924084152026-01-14
04055207069806NA8924084128924084122026-01-14
04055207069813NA8924084228924084222026-01-14
04055207069820NA8924084258924084252026-01-14
04055207069837NA8924089228924089222026-01-14
04055207069851NA8924089258924089252026-01-14
04055207036693POWER STICK M5/0899550000189955000012025-12-18
04055207000328NA20301052030.1052023-01-11
04055207067987VERTEBRIS8922012788922012782025-11-17
04055207067994VERTEBRIS8922020078922020072025-11-17
04055207068007VERTEBRIS8922020088922020082025-11-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00845225012939IntraSight PlusPhilips Image Guided Therapy CorporationOWB2026-05-26
00845225012946IntraSight PlusPhilips Image Guided Therapy CorporationOWB2026-05-26
00850073646144TrackXTrackX Technology, LLCOWB2026-05-26
08800098700156XPLUS 35 SeriesGEMSS Healthcare Co., Ltd.OWB2026-01-16
08800098700163XPLUS 35 SeriesGEMSS Healthcare Co., Ltd.OWB2026-01-16
00857088008844TrackXTrackX Technology, LLCOWB2025-12-08
08809244060618GenorayGENORAY CO., LTD.OWB2025-12-01
08809244060625GenorayGENORAY CO., LTD.OWB2025-12-01
08809244060700GenorayGENORAY CO., LTD.OWB2025-12-01
04056481145613Vascular Navigation PADBrainlab SEOWB2025-09-11
06971576833498uAngioShanghai United Imaging Healthcare Co., Ltd.OWB2025-08-03
04056869993980LUMINOS Q.namix TSiemens Healthcare GmbHOWB2025-07-30
00850073646007TrackXTrackX Technology, LLCOWB2025-07-24
00850073646014TrackXTrackX Technology, LLCOWB2025-07-24
08055186671096FUJIFILM Healthcare Americas CorporationA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2025-07-02
19120075320105Mobile Monitor Cart System MMCSmedPhoton GmbHOWB2025-06-10
19120075320136Remote Control Charging Cart RCCSmedPhoton GmbHOWB2025-06-10
19120075320112ImagingRing mmedPhoton GmbHOWB2025-05-28
19120075320129Loop-XmedPhoton GmbHOWB2025-05-28
00850073646038TrackXTrackX Technology, LLCOWB2025-05-16
08809244060090GenorayGENORAY CO., LTD.OWB2025-05-02
04987670100079CATHETERIZATION TABLECANON MEDICAL SYSTEMS CORPORATIONOWB2025-03-13
57613327664084Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OWB2025-02-11
00857088008875TrackXTrackX Technology, LLCOWB2025-02-07
00857088008943TrackXTrackX Technology, LLCOWB2025-02-07
00860001123418CassetteOXOS Medical, Inc.OWB2025-01-01
00860001123425EmitterOXOS Medical, Inc.OWB2025-01-01
00860008892706Foot PedalOXOS Medical, Inc.OWB2025-01-01
00860008892713Wired ChargerOXOS Medical, Inc.OWB2025-01-01
00860008892737CartOXOS Medical, Inc.OWB2025-01-01