[Ureteral Kit: 2
IRIS - 0220180518
Device Description
A flexible tube containing a fibreoptic bundle that emits light throughout its length, intended to be inserted into the ureter for (trans)illumination to facilitate visualization of the ureter. It is used to aid dissection during laparoscopic and/or open abdominal surgery; sometimes it is referred to as illuminating catheter. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: FCW
Device Name: Light Source, Fiberoptic, Routine
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 876.1500
Third Party Flag: N
Medical Specialty: GU
Code: FCS
Device Name: Light, Catheter, Fiberoptic, Glass, Ureteral
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 876.4020
Third Party Flag: N
Medical Specialty: GU
Device IdentifiersDevice Id: 37613327174817
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 07613327174816
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: pack
Device Id: 07613327174816
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A