"URF
URETERO-RENO FIBERSCOPE - OLYMPUS URF-P6
Device Description
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter and the renal pelvis. It is inserted through the external urethral orifice during a urological procedure. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used for the removal or crushing of stones, pyelitis, and renal failure. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- Ethylene Oxide
- Hydrogen Peroxide
Product Codes
Code: FGB
Device Name: Ureteroscope And Accessories, Flexible/Rigid
Device Class: 2
Physical State: endoscope, associated accessories
Definition: To perform various diagnostic and therapeutic procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Submission Type ID: 1
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Inserted into blood urinary tract through urethra
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: urinary tract
Regulation Number: 876.1500
Third Party Flag: N
Medical Specialty: GU
Code: FBN
Device Name: Choledochoscope And Accessories, Flexible/Rigid
Device Class: 2
Physical State: endoscope, accessories associated with choledochoscope
Definition: to examine and perform procedures within the bile ducts. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Submission Type ID: 1
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: instrument guided laparoscopically or through the esophagus into the biliary tree
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: bile ducts
Regulation Number: 876.1500
Third Party Flag: N
Medical Specialty: GU
Device IdentifiersDevice Id: 04953170340802
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
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