F88

Basic Information

• Brand Name: F88
• Primary DI: 08881300750077
• Version / Model: 0503388008
• Catalog Number: 0503388008
• 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: 9f607d5b-d1be-4ca7-b90f-58cdaac91f0f

Device Description

Manual Leak Tester

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
38460	Invasive medical device leak tester, mechanical	A hand-operated device intended to test an invasive medical device (e.g., flexible endoscope, ultrasound transducer) for leaks of air and/or fluid from its internal channels and/or housing by introducing air at increased pressures. It is typically a hand pump (e.g., a bulb) with a manometer and controls intended to be connected to the device tested. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08881300750077	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K243894	000