Single Use Loop Cutter FS-410

Basic Information

• Brand Name: Single Use Loop Cutter FS-410
• Primary DI: 04953170401053
• Version / Model: FS-410U
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Labeler DUNS: 711789789
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-21
• Public Version: 3
• Public Version Date: 2021-12-17
• Public Version Status: Update
• Public Device Record Key: bc2693aa-331c-4757-b0df-29c1a83fad13

Device Description

Single Use Loop Cutter FS-410

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PTS	Endoscopic grasping/cutting instrument, non-powered, exempt	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46420	Flexible endoscopic scissors, single-use	A flexible device used in combination with a dedicated endoscope and intended to cut tissue or sutures during an endoscopic procedure. It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a pair of cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working channel of the endoscope. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14953170401050	GS1		1	In Commercial Distribution
Primary	04953170401053	GS1

Customer Contacts

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