Boa Vision

FDA UDI

Class II (US FDA UDI)

by Richard Wolf GmbH

Identity

Trade Name: BOA VISION FDA UDI
Generic Name: Flexible video ureterorenoscope, reusable FDA UDI
Device Name: 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 FDA UDI
Model / Reference: 7355071 FDA UDI
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 FDA UDI

Identifiers

Catalog Number: 7355071 FDA UDI
Primary DI / UDI-DI: 04055207054840 FDA UDI
FDA Product Code: FGB FDA UDI
FGA FDA UDI
GMDN Term: Flexible video ureterorenoscope, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Hydrogen Peroxide FDA UDI

Dimensions & Sizes

Size: Length — 680 Millimeter FDA UDI
Outer Diameter — 2.9 Millimeter FDA UDI

Category: Flexible video ureterorenoscope, reusable

Boa Vision by Richard Wolf GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible video ureterorenoscope, reusable.

Flex-X — Karl Storz GmbH & Co. KG · Class II
Flex-X — Karl Storz GmbH & Co. KG · Class II
URETERO-RENO VIDEOSCOPE — Olympus Medical Systems Corporation · Class II
Flex-X — Karl Storz GmbH & Co. KG · Class II
Flex-X / IMAGE 1 S — Karl Storz GmbH & Co. KG · Class II
URETERO-RENO VIDEOSCOPE — Olympus Medical Systems Corporation · Class II
Flex-X — Karl Storz GmbH & Co. KG · Class II
Flex-X / IMAGE 1 S — Karl Storz GmbH & Co. KG · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Richard Wolf GmbH

Sources (1)

FDA UDI d0712bd2-ff9d-446e-b7f2-7eb1315d7d1d 36 fields · synced Jun 8, 2026