F88

Basic Information

• Brand Name: F88
• Primary DI: 08881300750107
• Version / Model: 0503388001
• Catalog Number: 0503388001
• Company Name: SG ENDOSCOPY PTE. LTD.
• Labeler DUNS: 595455258
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2025-06-30
• Public Version: 3
• Public Version Date: 2025-07-21
• Public Version Status: Update
• Public Device Record Key: 33c3994f-6fd7-43bc-b3f6-f5fb460887e2

Device Description

Single Luer Stopcock

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: No
• Has Lot/Batch Number: Yes
• 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
64366	Endoscope working-channel valve, reusable	A device in the form of a small attachment intended to be fitted to the working channel (including biopsy port) of an endoscope to enable access for, and/or exchange of, an endoscopic device while minimizing leakage of liquids and gasses during an endoscopic procedure. Also referred to as a seal, it may be Luer formatted and include features to allow for simultaneous irrigation/biopsy or suction via the working channel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	08881300750046	GS1
Primary	08881300750107	GS1

Premarket Submissions

Submission Number	Supplement Number
K243894	000