FDA.reportPublic FDA data

BOA VISION

Primary DI
00814334022832
Brand
BOA VISION
Company
Richard Wolf GmbH
Model
7355076US
Catalog number
7355076US
Device description
SENSOR-URETERORENOSCOPE 8.7FR WL 680MM flexible, working channel 3.6Fr, slanted distal tip Ø 6.6Fr, TL 980mm, deflection +270°/-270°, two function buttons, for connection to ENDOCAM Logic HD, LED-illumination, distal Sensor, Fixfocus
Published
2021-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FGAKit, nephroscope
FGBUreteroscope and accessories, flexible/rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGAKit, NephroscopeGastroenterology, Urology2
FGBUreteroscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814334022832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814334022832008143340228328143340228320814334022832

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video ureterorenoscope, reusableAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter and renal pelvis. It is inserted through the external urethral orifice or a surgically-created percutaneous route during a urological procedure. Anatomical images are transmitted to the user by a video system with an electronic image sensor at the distal end of the endoscope and the images showing on a monitor. This device is commonly used for the removal or crushing of stones, and evaluation of pyelitis and renal failure. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length680Millimeter
Outer Diameter2.9Millimeter

Sterilization Methods#

Method table
Method
Hydrogen Peroxide

Contacts#

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

Regulatory Flags#

DUNS number
315304071
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

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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

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