F88

Basic Information

• Brand Name: F88
• Primary DI: 08881300750084
• Version / Model: 0502388100
• Catalog Number: 0502388100
• Company Name: SG ENDOSCOPY PTE. LTD.
• Labeler DUNS: 595455258
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-30
• Public Version: 4
• Public Version Date: 2025-07-21
• Public Version Status: Update
• Public Device Record Key: 7c5d79eb-f250-4c51-aec3-72400d85ee66

Device Description

Flexible Ureteroscope, Standard Deflection

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Hydrogen Peroxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38689	Flexible video ureteroscope, reusable	An endoscope with a flexible 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 by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. This device is commonly used for biopsies, endoscopic lithotripsy, treatment of upper urinary tract malignancies, incising strictures, and repairing ureteropelvic junction obstructions. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08881300750084	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K243894	000