FDA.reportPublic FDA data

RIWOLITH

Primary DI
04055207038055
Brand
RIWOLITH
Company
Richard Wolf GmbH
Model
2280093
Catalog number
2280.093
Device description
PROBE 9FR WL 474MM PACK=3 PCS, sterile, for single use
Published
2017-06-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFKLithotriptor, electro-hydraulic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFKLithotriptor, Electro-HydraulicGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207038055PrimaryGS10
04055207049761Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207038055040552070380554055207038055
04055207049761040552070497614055207049761

GMDN Terms#

Term, Definition table
TermDefinition
Electrohydraulic lithotripsy systemAn assembly of devices that uses plasma-induced shock waves for the intracorporeal fragmentation of stones (calculi) found in the kidney, ureter, and bladder. It typically comprises a generator-powered probe which fires energy pulses at the stone's centre while the probe is irrigated with a saline solution. The collapse of the resulting plasma bubble causes a hydraulic shock that fragments the stone into several pieces which can then be removed using surgical instruments (e.g., a grasping instrument or stone basket).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length474Millimeter
Outer Diameter3Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags#

DUNS number
315304071
Device count
3
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04055207066805NA880888.082026-06-02
04055207007709NA180118.012026-05-29
04055207007723RIWO880388.032026-05-29
04055207007747NA890089.002026-05-29
04055207007792NA890589.052026-05-29
04055207007815NA890989.092026-05-29
04055207007839NA892089.202026-05-29
04055207008409NA8917189.1712026-05-29
04055207038505RIWO880088.002026-05-29
04055207038529RIWO880288.022026-05-29
04055207038536RIWO880488.042026-05-29
04055207011478NA8863758863.752026-05-19
04055207011539NA8913608913.602026-05-19
04055207054390NA417022284170.22282026-05-19
04055207048788NA484076448407642026-05-13
04055207008881NA8061168061.162016-09-23
04055207008898NA8061258061.252016-09-23
04055207008904NA8061358061.352016-09-23
04055207008911NA8062358062.352016-09-23
04055207012611NA40702534070.2532016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260667540257EL27-CompactWalz Elektronik GmbHFFK2025-11-12
06973204210763Electrohydraulic LithotriptorGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.FFK2025-06-26
06973204210787EHL ProbeGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.FFK2025-06-26
06973204210794EHL ProbeGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.FFK2025-06-26
06973204210800EHL ProbeGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.FFK2025-06-26
07613353125929LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-09-03
00821925044173CYBERWANDGyrus ACMI, LLCFFK2024-07-25
00821925043596CYBERWANDGyrus Acmi, Inc.FFK2024-07-25
07613353222413LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353311582LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353221836LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353311568LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353311575LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353176686LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353312046LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353214159LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2023-11-22
07613353214203LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2023-11-22
04260667540011EL27-CompactWalz Elektronik GmbHFFK2023-10-25
04260667540059EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540097EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540110EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540134EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540158EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540172EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540196EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540219EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
07290016498455LithospecMEDISPEC LTD.FFK2023-06-08
07613353187101SWISS DolorClastE.M.S. Electro Medical Systems S.A.FFK2022-10-28
07613353001940LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2021-09-17
07613353001964LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2021-09-17