F88

Basic Information

• Brand Name: F88
• Primary DI: 08881300750060
• Version / Model: 0503388007
• Catalog Number: 0503388007
• 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: f025df57-11b4-4874-ace9-b5314f92335f

Device Description

Vent Cap

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: No

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
65839	Endoscope fluid protection cap	A small, closed-ended attachment intended to be attached to an endoscope channel/port (e.g., light source socket) to prevent exposure of the endoscope interior to fluids during sterilization/cleaning; it is not intended to be used during a medical procedure and does not incorporate a filter or valve. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08881300750060	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K243894	000