DEVICE: COBRA VISION (04055207054864)
Device Identifier (DI) Information
COBRA VISION
7356071
In Commercial Distribution
7356071
Richard Wolf GmbH
7356071
In Commercial Distribution
7356071
Richard Wolf GmbH
SENSOR-URETERORENOSCOPE 9.9FR WL 680MM flexible, working channel 1: 3.6Fr, working channel 2: 2.4Fr, double slanted distal tip Ø 5,2Fr, TL 980mm, deflection +270°/-270°, laser shifter for laser fiber fixation and guidance, locking lever for the distal tip, two function buttons, for connection to ENDOCAM Logic HD, LED-illumination, distal Sensor, Fixfocus
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
38703 | Flexible video ureterorenoscope, reusable |
An 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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FGB | Ureteroscope and accessories, flexible/rigid |
FGA | Kit, nephroscope |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 3.3 Millimeter |
Length: 680 Millimeter |
Device Record Status
ddaa2606-cf09-49fb-8145-26e639711f15
September 15, 2021
8
September 23, 2016
September 15, 2021
8
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+497043350
info@richard-wolf.com
info@richard-wolf.com