6.9/10 Fr. SRU-6X, Semi-Rigid Ureteroscope, Autoclavable

6.9/10 Fr. SRU
NA - 0502880430

An endoscope with a rigid inserted portion intended for the visual examination and treatment of the ureter, (the upper urinary tract that connects the kidney to the bladder). It is inserted through the external urethral orifice and bladder during ureteroscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used for biopsies, endoscopic lithotripsy, treatment of upper urinary tract malignancies, incising strictures, and repairing ureteropelvic junction obstructions. This is a reusable device.

No Data Available

• Length: 43.0 Centimeter

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Moist Heat or Steam Sterilization

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

Device Id: 07613327063592

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