RIWOLITH 2280.433

GUDID 04055207038147

PROBE 3.3FR WL 1050MM PACK=3 PCS, sterile, for single use

Richard Wolf GmbH

Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system
Primary Device ID04055207038147
NIH Device Record Keyed8e1259-0f4c-4bd2-b822-d28e12ba7d28
Commercial Distribution StatusIn Commercial Distribution
Brand NameRIWOLITH
Version Model Number2280433
Catalog Number2280.433
Company DUNS315304071
Company NameRichard Wolf GmbH
Device Count3
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com

Device Dimensions

Outer Diameter1.1 Millimeter
Outer Diameter1.1 Millimeter
Length1050 Millimeter
Outer Diameter1.1 Millimeter
Length1050 Millimeter
Outer Diameter1.1 Millimeter
Length1050 Millimeter
Outer Diameter1.1 Millimeter
Length1050 Millimeter
Outer Diameter1.1 Millimeter
Length1050 Millimeter
Outer Diameter1.1 Millimeter
Length1050 Millimeter
Outer Diameter1.1 Millimeter
Length1050 Millimeter
Outer Diameter1.1 Millimeter
Length1050 Millimeter
Outer Diameter1.1 Millimeter
Length1050 Millimeter
Outer Diameter1.1 Millimeter
Length1050 Millimeter
Outer Diameter1.1 Millimeter
Length1050 Millimeter
Outer Diameter1.1 Millimeter
Length1050 Millimeter
Outer Diameter1.1 Millimeter
Length1050 Millimeter
Outer Diameter1.1 Millimeter
Length1050 Millimeter
Outer Diameter1.1 Millimeter
Length1050 Millimeter
Outer Diameter1.1 Millimeter
Length1050 Millimeter
Outer Diameter1.1 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 and 5 Degrees Celsius
Storage Environment TemperatureBetween 0 and 5 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS104055207038147 [Primary]
GS104055207049853 [Unit of Use]

FDA Product Code

FFKLithotriptor, electro-hydraulic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-05-09
Device Publish Date2017-06-28

On-Brand Devices [RIWOLITH]

00814334020876EHL PROBE Ø 5FR WL 770MM for single use
00814334020852EHL PROBE Ø 9FR WL 470MM for single use
00814334020838EHL PROBE Ø 5FR WL 770MM for single use
04055207038147PROBE 3.3FR WL 1050MM PACK=3 PCS, sterile, for single use
04055207038130PROBE 2.4FR WL 1050MM PACK=3 PCS, sterile, for single use
04055207038123PROBE 3.3FR WL 700MM PACK=3 PCS, sterile, for single use
04055207038116PROBE 2.4FR WL 700MM PACK=3 PCS, sterile, for single use
04055207038109PROBE 3.3FR WL 1050MM PACK=3 PCS, sterile, for single use
04055207038093PROBE 2.4FR WL 1050MM PACK=3 PCS, sterile, for single use
04055207038086PROBE 5FR WL 770MM PACK=3 PCS, sterile, for single use
04055207038079PROBE 3.3FR WL 700MM PACK=3 PCS, sterile, for single use
04055207038062PROBE 2.4FR WL 700MM PACK=3 PCS, sterile, for single use
04055207038055PROBE 9FR WL 474MM PACK=3 PCS, sterile, for single use
04055207012185CONNECTION CABLE for RIWOLITH probes

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